Die Suche nach "Quality Assurance"-Positionen bietet vielfältige Möglichkeiten für Fachkräfte, die sich mit der Sicherstellung und Verbesserung der Produkt- und Dienstleistungsqualität beschäftigen. Diese Rollen sind in verschiedenen Branchen gefragt, darunter IT, Fertigung und Gesundheitswesen. Die Verantwortlichkeiten umfassen die Entwicklung und Implementierung von Qualitätssicherungsprozessen, die Durchführung von Audits und die Identifizierung von Verbesserungspotenzialen.26 Jobs für Quality Assurance in Schweiz
Quality Assurance Specialist
Grifols Shared Services North America, Inc
Vor 24 Tagen gepostet
Job angesehen
Arbeitsbeschreibung
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
**We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.**
We are searching for a QA SPECIALIST.
**What your responsibilities will be**
+ You will ensure that manufacturing practices and operations comply with internal and external regulations, with a special focus on Change Control processes.
+ You will initiate and follow up on Change Controls, perform risk and impact assessments, and coordinate implementation and documentation.
+ You will lead internal Change Control meetings and collaborate with all involved stakeholders.
+ You will manage failure investigations, perform root cause analysis, and initiate appropriate CAPAs.
+ You will support the preparation of Management Reviews and the technical market release process.
**Who you are**
+ You have a university degree in a scientific or technical field.
+ You have experience in Quality Assurance within a GMP-regulated environment.
+ You are familiar with risk assessment methodologies, Change Control processes and QMS tools.
+ You have strong analytical, organizational, and communication skills.
+ You are fluent in English; knowledge of German and/or French is a plus.
+ You are a team player with a systematic and proactive approach.
**What we offer**
It's a brilliant opportunity for someone with the right talents.
You'll join a collaborative and innovative team committed to quality and continuous improvement.
We offer professional development opportunities and a chance to contribute to life-saving diagnostic products.
**Contract of Employment:** Permanent position
**Flexibility for U Program:** 1 day remote working possible
#LI-HJ1
**Location: EMEA : Switzerland : Düdingen:Suiza**
Learn more about Grifols ( ID:** 531487
**Type:** Regular Full-Time
**Job Category:**
**We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.**
We are searching for a QA SPECIALIST.
**What your responsibilities will be**
+ You will ensure that manufacturing practices and operations comply with internal and external regulations, with a special focus on Change Control processes.
+ You will initiate and follow up on Change Controls, perform risk and impact assessments, and coordinate implementation and documentation.
+ You will lead internal Change Control meetings and collaborate with all involved stakeholders.
+ You will manage failure investigations, perform root cause analysis, and initiate appropriate CAPAs.
+ You will support the preparation of Management Reviews and the technical market release process.
**Who you are**
+ You have a university degree in a scientific or technical field.
+ You have experience in Quality Assurance within a GMP-regulated environment.
+ You are familiar with risk assessment methodologies, Change Control processes and QMS tools.
+ You have strong analytical, organizational, and communication skills.
+ You are fluent in English; knowledge of German and/or French is a plus.
+ You are a team player with a systematic and proactive approach.
**What we offer**
It's a brilliant opportunity for someone with the right talents.
You'll join a collaborative and innovative team committed to quality and continuous improvement.
We offer professional development opportunities and a chance to contribute to life-saving diagnostic products.
**Contract of Employment:** Permanent position
**Flexibility for U Program:** 1 day remote working possible
#LI-HJ1
**Location: EMEA : Switzerland : Düdingen:Suiza**
Learn more about Grifols ( ID:** 531487
**Type:** Regular Full-Time
**Job Category:**
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0
Quality Assurance Manager
Gi Group SA
Vor 11 Tagen gepostet
Job angesehen
Arbeitsbeschreibung
For our client's company in Basel, we are looking for a
Quality Assurance Manager
- You review and approve SOP's, protocols, reports, Certificate of Analysis and other quality-related documents
- You have a high sense of detail orientation and support investigations of deviations and out of specifications (OOS)
- You maintain, record and process corrective and preventive measures (CAPA's)
- You act as a Quality Assurance point of contact for our customers
- You have a high level of customer orientation and you organize and manage customer audits and inspections
- You apply and interpret audit and compliance requirements
- You perform internal audits and provide support for GMP training
Requirements
- You have a scientific education (Master degree) in analytical chemistry, biochemistry or life sciences
- You are fluent in English and German
- You worked for at least 7 years in the analytical-pharmaceutical environment having preferably proven experience in Quality Assurance
- You have profound expertise in the regulatory framework in the GMP environment such as ICH, FDA, USAP, Ph. Eur.
- You have a background in data integrity and computerized systems, risk assessment and project support
- You convince us with your problem-solving skills and outstanding communication skills to collaborate with your future team-members and various stakeholders
- If you have gained experience as an auditor, then this is an asset
Branche: Pharma-Industrie
Funktion: Qualitätsprüfung
Anstellungsart: Festanstellung
Karrierestufe: Management
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1
Scientist Quality Assurance Qualification
Lengnau, Bern
ThermoFisher Scientific
Vor 3 Tagen gepostet
Job angesehen
Arbeitsbeschreibung
**Work Schedule**
Standard Office Hours (40/wk)
**Environmental Conditions**
Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
**Job Description**
**Position Purpose**
The main responsibilities of this position are:
+ Involved in all GMP aspects of the execution of commissioning and qualification activities, ensuring quality, working closely with the Engineering Services as well CVQ to deliver innovative qualified facilities, utilities and equipment, ready for commercial production.
+ Active involvement in issue assessment and management, especially in collaboration with Engineering and CVQ.
+ Continuously improving quality standards for assigned quality systems and relevant production areas.
+ The role supports and encourages active knowledge management within the assigned department and drive continuous improvement processes.
**Position Relationships**
The position reports to:
+ Manager QM Qualification - Lengnau
The position interacts with:
+ Quality Management, QC and other QA functions, Lengnau
+ Manufacturing Science & Technology (MSAT), Lengnau
+ Drug Substance Manufacturing, Lengnau
+ Execution Systems, Lengnau
+ Engineering & Facilities, Lengnau
**Position Responsibilities & Accountabilities**
Technical Responsibilities
+ QA representative for C&Q activities in any assigned C&Q team.
+ Ensures as QA representative the compliance Quality of all elements (e.g. URS, QRA) leading to C&Q activities (DQ, IQ, OQ, and PQ).
+ Review and approves C&Q system specific documentation TURS, RTM, QRA, IOC - if applicable, IQ, OQ, PQ, QR according to internal standards.
+ Assess and reviews punches, project deviations occurred on assigned systems during C&Q phase
+ Establish basic documents (SOPs, WIs, etc.) based on request governing C&Q under the supervision of the direct manager within the reporting line.
**Quality**
+ Follows cGMP rules, quality policies, procedures and instruction as rolled out by the quality function and endorsed by the site management.
+ Actively participates in quality improvement initiatives and deviation reporting and follow-up.
**EHSS**
+ Adheres to general safety rules. Proactively supports safety initiatives and issues as well as near miss.
**Values & behavior**
+ Maintains dedication to Thermo Fisher Scientific values and adherence to ethics and legal compliance standards.
+ Takes personal accountability for their presence, performance, and efficiency for the achievements of defined objectives.
+ Thinks and acts with a customer-centric approach.
+ Is intellectually curious and accepts practical process improvement (PPI).
**Position Qualifications**
**Education**
+ Degree (Bachelor or Masters) in Engineering or Life Science (Biology, Chemistry, etc.) Dipl. or M.Sc. Or B.Sc.
**Experience & competences**
+ Qualification experience preferably gained on a Life Sciences / Pharma / Biotech Upstream / Downstream facility.
+ Several years of successful commissioning and/or qualification experience on midsized and major projects with high complexity in the chemical, biotech or pharmaceutical industry.
+ Confirmed experience in cGMP, Qualification and Quality Risk Management.
+ Language: proficient in English and preferably in German required.
+ Excellent time management skills, with the flexibility to handle changing priorities and multiple tasks.
**Additional requirements**
+ N/A
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard Office Hours (40/wk)
**Environmental Conditions**
Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
**Job Description**
**Position Purpose**
The main responsibilities of this position are:
+ Involved in all GMP aspects of the execution of commissioning and qualification activities, ensuring quality, working closely with the Engineering Services as well CVQ to deliver innovative qualified facilities, utilities and equipment, ready for commercial production.
+ Active involvement in issue assessment and management, especially in collaboration with Engineering and CVQ.
+ Continuously improving quality standards for assigned quality systems and relevant production areas.
+ The role supports and encourages active knowledge management within the assigned department and drive continuous improvement processes.
**Position Relationships**
The position reports to:
+ Manager QM Qualification - Lengnau
The position interacts with:
+ Quality Management, QC and other QA functions, Lengnau
+ Manufacturing Science & Technology (MSAT), Lengnau
+ Drug Substance Manufacturing, Lengnau
+ Execution Systems, Lengnau
+ Engineering & Facilities, Lengnau
**Position Responsibilities & Accountabilities**
Technical Responsibilities
+ QA representative for C&Q activities in any assigned C&Q team.
+ Ensures as QA representative the compliance Quality of all elements (e.g. URS, QRA) leading to C&Q activities (DQ, IQ, OQ, and PQ).
+ Review and approves C&Q system specific documentation TURS, RTM, QRA, IOC - if applicable, IQ, OQ, PQ, QR according to internal standards.
+ Assess and reviews punches, project deviations occurred on assigned systems during C&Q phase
+ Establish basic documents (SOPs, WIs, etc.) based on request governing C&Q under the supervision of the direct manager within the reporting line.
**Quality**
+ Follows cGMP rules, quality policies, procedures and instruction as rolled out by the quality function and endorsed by the site management.
+ Actively participates in quality improvement initiatives and deviation reporting and follow-up.
**EHSS**
+ Adheres to general safety rules. Proactively supports safety initiatives and issues as well as near miss.
**Values & behavior**
+ Maintains dedication to Thermo Fisher Scientific values and adherence to ethics and legal compliance standards.
+ Takes personal accountability for their presence, performance, and efficiency for the achievements of defined objectives.
+ Thinks and acts with a customer-centric approach.
+ Is intellectually curious and accepts practical process improvement (PPI).
**Position Qualifications**
**Education**
+ Degree (Bachelor or Masters) in Engineering or Life Science (Biology, Chemistry, etc.) Dipl. or M.Sc. Or B.Sc.
**Experience & competences**
+ Qualification experience preferably gained on a Life Sciences / Pharma / Biotech Upstream / Downstream facility.
+ Several years of successful commissioning and/or qualification experience on midsized and major projects with high complexity in the chemical, biotech or pharmaceutical industry.
+ Confirmed experience in cGMP, Qualification and Quality Risk Management.
+ Language: proficient in English and preferably in German required.
+ Excellent time management skills, with the flexibility to handle changing priorities and multiple tasks.
**Additional requirements**
+ N/A
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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2
Scientist Quality Assurance Operations
Lengnau, Bern
ThermoFisher Scientific
Vor 4 Tagen gepostet
Job angesehen
Arbeitsbeschreibung
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
**Job Description**
**Join Thermo Fisher Scientific Inc. for an exceptionally rewarding career where your contributions help craft the future of science and health!**
**Job Description**
As an engineer at Thermo Fisher Scientific Inc., you will be at the forefront of innovation and excellence in the pharmaceutical industry. Your work will be crucial in ensuring the flawless execution of our manufacturing processes and the successful implementation of quality and compliance measures.
**Responsibilities:**
+ Ensure compliance of the manufacturing processes, batch record, deviation, change control, and CAPA.
+ Review and approve completed batch records within defined timelines.
+ Responsible for technical batch release.
+ Provide active on-the-floor support to the production team.
+ Review and approve operational elements such as procedures and related documents, including specifications, working instructions, and impact assessments.
+ Assist with continuous improvement initiatives related to quality documents and processes.
+ Supervise the preparation of the Annual Product Review (APQR) and ensure its execution within the due date.
+ Be present on the floor during critical manufacturing steps.
+ Uphold and share data integrity rules (ALCOA+).
+ Propose improvements to flows, manufacturing activities, and organizational processes.
**Qualifications:**
+ Seeking pharmacists or scientists with a master's degree or equivalent experience. Requires 3-5 years in pharma (biotech) and 1 year in commercial batch release.
+ In-depth knowledge of pharmaceutical manufacturing processes, particularly biologic drug substances.
+ Proficient in German and English, with strong oral and written communication skills.
+ Experience with SAP and electronic MES (manufacturing execution system) is a plus.
+ Ability to provide on-call services remotely based on departmental needs.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
**Job Description**
**Join Thermo Fisher Scientific Inc. for an exceptionally rewarding career where your contributions help craft the future of science and health!**
**Job Description**
As an engineer at Thermo Fisher Scientific Inc., you will be at the forefront of innovation and excellence in the pharmaceutical industry. Your work will be crucial in ensuring the flawless execution of our manufacturing processes and the successful implementation of quality and compliance measures.
**Responsibilities:**
+ Ensure compliance of the manufacturing processes, batch record, deviation, change control, and CAPA.
+ Review and approve completed batch records within defined timelines.
+ Responsible for technical batch release.
+ Provide active on-the-floor support to the production team.
+ Review and approve operational elements such as procedures and related documents, including specifications, working instructions, and impact assessments.
+ Assist with continuous improvement initiatives related to quality documents and processes.
+ Supervise the preparation of the Annual Product Review (APQR) and ensure its execution within the due date.
+ Be present on the floor during critical manufacturing steps.
+ Uphold and share data integrity rules (ALCOA+).
+ Propose improvements to flows, manufacturing activities, and organizational processes.
**Qualifications:**
+ Seeking pharmacists or scientists with a master's degree or equivalent experience. Requires 3-5 years in pharma (biotech) and 1 year in commercial batch release.
+ In-depth knowledge of pharmaceutical manufacturing processes, particularly biologic drug substances.
+ Proficient in German and English, with strong oral and written communication skills.
+ Experience with SAP and electronic MES (manufacturing execution system) is a plus.
+ Ability to provide on-call services remotely based on departmental needs.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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3
Senior Manager Quality Assurance
Zürich, Zürich
Abbott
Vor 10 Tagen gepostet
Job angesehen
Arbeitsbeschreibung
**Thoratec Switzerland GmbH** is part of the medical device division of **Abbott Laboratories** , a fortune 500 company with over 115'000 employees worldwide. We are the global market leader for implantable and extracorporeal blood pumps based on magnetic levitation technology. Our life-saving systems, which we develop and manufacture in Zurich, are used for advanced heart failure patients needing short- or long-term circulatory support.
Our location in the heart of the city of Zurich has around 130 employees in the areas of development, quality and production of the **CentriMag** system and the **HeartMate 3.**
Are you a strategic leader passionate about quality, innovation, and making a difference in healthcare? Join our Zurich team as **Senior Manager Quality Assurance** , where you'll lead with purpose, foster collaboration, and shape the future of our quality systems in a dynamic and inclusive environment.
**Position Overview**
As the **Senior** **Quality Manager Quality Assurance** for our Zurich site, you'll be the key point of contact for all quality-related matters, including interactions with external regulators and Notified Bodies. You'll lead the development and execution of our site's Quality strategy, ensuring alignment with global standards and business goals, while championing continuous improvement and operational excellence.
This role offers a unique opportunity to influence site-wide strategy, guide cross-functional teams, and support the expansion of manufacturing capabilities, including clean room processes. You'll work closely with senior leadership and empower a talented team to deliver high-quality, safe, and compliant products that improve lives.
**Key Responsibilities**
**Compliance & Regulatory Leadership**
+ Serve as the Quality Management Representative for the Zurich site and manufacturer of the Centrimag product line.
+ Ensure compliance with global quality system regulations (USA, EU, Korea, Brazil, Australia, Canada, Ukraine, Switzerland).
+ Lead site readiness for inspections and audits, and represent the facility during regulatory and internal audits.
**Team Leadership & Development**
+ Lead and mentor a diverse team across operations quality, regulatory compliance, supplier quality, and new product development.
+ Foster a culture of inclusion, collaboration, and continuous learning.
+ Identify and manage resource needs to support operational excellence and future growth.
**Quality Systems & Process Excellence**
+ Oversee quality system processes including document control, CAPA, risk management, supplier evaluations, and complaint handling.
+ Support centralized functions like Regulatory Affairs and vigilance reporting with timely and accurate data.
+ Drive improvements through data analysis and quality management reviews.
**Product Acceptance & Customer Safety**
+ Own final decisions on product quality and release, ensuring compliance and customer protection.
+ Manage non-conformance evaluations and ensure timely resolution aligned with patient safety.
**Strategic Planning & Budget Management**
+ Plan and manage the Quality department budget in alignment with business objectives.
+ Collaborate with Finance, Site Director, and divisional leadership to ensure responsible and strategic resource allocation.
**Cross-Functional Collaboration**
+ Partner with Operations, R&D, and external stakeholders to resolve quality issues and support product development.
+ Contribute to Zurich site strategy and support the integration of new manufacturing processes.
**Qualifications - What Will Help You Thrive in This Role**
+ A **Master's degree** in Science, Engineering, or a related technical field, with **10+ years of experience** in the medical device industry.
+ At least **5 years of leadership experience** in a quality systems environment, ideally within medical devices.
+ Strong understanding of **ISO standards** and global regulatory frameworks (e.g., US, EU) related to medical devices.
+ Proven ability to **lead and inspire teams** , with a focus on coaching, development, and inclusive leadership.
+ Comfortable using business and technical software tools; open to learning new systems.
+ Strong analytical and decision-making skills, with a collaborative and solution-oriented mindset.
+ Excellent communication skills in English, with German proficiency considered an asset for engaging a broad range of stakeholders.
+ Able to work independently and collaboratively across **global teams** , including remote sites.
+ Highly organized, with strong time management and prioritization abilities.
+ Skilled in building relationships and navigating complex environments with empathy and professionalism.
+ Committed to ethical standards and delivering high-quality outcomes.
**Working at Abbott**
At Abbott, you can do work that matters and help people to live a healthier and fuller life, grow your career, and learn, be your true self. You will have access to:
+ Career development with an international company where you can grow
+ A workplace in a fortune 500 company and the world's leading manufacturer of medical devices
+ A challenging position in a crisis independent industry
+ To become part of a dynamic, highly educated, highly skilled, and motivated team
+ Multi-national environment, where we foster the development of our talents within the enterprise
+ Competitive compensations and benefits
+ A workplace in the heart of Zurich
Please follow our Career site and check for available openings:
Abbott Jobs | Apply Now | Abbott Laboratories Careers ( Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
Our location in the heart of the city of Zurich has around 130 employees in the areas of development, quality and production of the **CentriMag** system and the **HeartMate 3.**
Are you a strategic leader passionate about quality, innovation, and making a difference in healthcare? Join our Zurich team as **Senior Manager Quality Assurance** , where you'll lead with purpose, foster collaboration, and shape the future of our quality systems in a dynamic and inclusive environment.
**Position Overview**
As the **Senior** **Quality Manager Quality Assurance** for our Zurich site, you'll be the key point of contact for all quality-related matters, including interactions with external regulators and Notified Bodies. You'll lead the development and execution of our site's Quality strategy, ensuring alignment with global standards and business goals, while championing continuous improvement and operational excellence.
This role offers a unique opportunity to influence site-wide strategy, guide cross-functional teams, and support the expansion of manufacturing capabilities, including clean room processes. You'll work closely with senior leadership and empower a talented team to deliver high-quality, safe, and compliant products that improve lives.
**Key Responsibilities**
**Compliance & Regulatory Leadership**
+ Serve as the Quality Management Representative for the Zurich site and manufacturer of the Centrimag product line.
+ Ensure compliance with global quality system regulations (USA, EU, Korea, Brazil, Australia, Canada, Ukraine, Switzerland).
+ Lead site readiness for inspections and audits, and represent the facility during regulatory and internal audits.
**Team Leadership & Development**
+ Lead and mentor a diverse team across operations quality, regulatory compliance, supplier quality, and new product development.
+ Foster a culture of inclusion, collaboration, and continuous learning.
+ Identify and manage resource needs to support operational excellence and future growth.
**Quality Systems & Process Excellence**
+ Oversee quality system processes including document control, CAPA, risk management, supplier evaluations, and complaint handling.
+ Support centralized functions like Regulatory Affairs and vigilance reporting with timely and accurate data.
+ Drive improvements through data analysis and quality management reviews.
**Product Acceptance & Customer Safety**
+ Own final decisions on product quality and release, ensuring compliance and customer protection.
+ Manage non-conformance evaluations and ensure timely resolution aligned with patient safety.
**Strategic Planning & Budget Management**
+ Plan and manage the Quality department budget in alignment with business objectives.
+ Collaborate with Finance, Site Director, and divisional leadership to ensure responsible and strategic resource allocation.
**Cross-Functional Collaboration**
+ Partner with Operations, R&D, and external stakeholders to resolve quality issues and support product development.
+ Contribute to Zurich site strategy and support the integration of new manufacturing processes.
**Qualifications - What Will Help You Thrive in This Role**
+ A **Master's degree** in Science, Engineering, or a related technical field, with **10+ years of experience** in the medical device industry.
+ At least **5 years of leadership experience** in a quality systems environment, ideally within medical devices.
+ Strong understanding of **ISO standards** and global regulatory frameworks (e.g., US, EU) related to medical devices.
+ Proven ability to **lead and inspire teams** , with a focus on coaching, development, and inclusive leadership.
+ Comfortable using business and technical software tools; open to learning new systems.
+ Strong analytical and decision-making skills, with a collaborative and solution-oriented mindset.
+ Excellent communication skills in English, with German proficiency considered an asset for engaging a broad range of stakeholders.
+ Able to work independently and collaboratively across **global teams** , including remote sites.
+ Highly organized, with strong time management and prioritization abilities.
+ Skilled in building relationships and navigating complex environments with empathy and professionalism.
+ Committed to ethical standards and delivering high-quality outcomes.
**Working at Abbott**
At Abbott, you can do work that matters and help people to live a healthier and fuller life, grow your career, and learn, be your true self. You will have access to:
+ Career development with an international company where you can grow
+ A workplace in a fortune 500 company and the world's leading manufacturer of medical devices
+ A challenging position in a crisis independent industry
+ To become part of a dynamic, highly educated, highly skilled, and motivated team
+ Multi-national environment, where we foster the development of our talents within the enterprise
+ Competitive compensations and benefits
+ A workplace in the heart of Zurich
Please follow our Career site and check for available openings:
Abbott Jobs | Apply Now | Abbott Laboratories Careers ( Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
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4
Global Quality Assurance Manager
Zug, Zug
beBeeAuditor
Heute
Job angesehen
Arbeitsbeschreibung
Quality Assurance Specialist
We are seeking a skilled Quality Assurance Specialist to support Strategic and Project Procurement by ensuring the highest quality standards across our global supply chain.
- Conduct supplier audits, provide expert consultation to procurement teams on quality management processes and methodologies, and collaborate with multiple business functions such as IT, Product Development, Project Management, Procurement, and Quality Assurance.
- Engage with the auditor community to ensure consistency and excellence in quality assessments.
- Monitor and evaluate supplier performance by tracking key performance metrics and generating detailed evaluation reports through our platforms.
- Support claims management, the 8D process, and guide Global Commodity Managers on quality-related issues, ensuring robust Quality Assurance Agreement monitoring.
- Contribute to strategic initiatives by assisting in negotiations for quality contracts, developing supplier strategies, and ensuring branding compliance.
To succeed in this role, you will need:
- Bachelor's degree or equivalent, Master's degree preferred or relevant business or technical experience.
- Experience in Supplier Auditing and Quality Assurance with proven track record of conducting supplier audits, managing follow-ups, and ensuring compliance with quality standards across a global supply chain.
- Strong knowledge of Quality Management Systems and Processes with deep understanding of quality methodologies (e.g., 8D, claims management, Quality Assurance Agreements) and the ability to guide procurement teams on quality-related best practices.
- Technical Proficiency with Digital Quality Tools and Platforms, including data analysis and reporting capabilities.
You should be comfortable working in a dynamic, global environment, collaborating with multiple stakeholders, and in a digital set-up to drive quality excellence. Additionally, being a proactive team member, good at negotiating, and seeking constructive agreements with a continuous improvement mindset is essential.
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5
QUALITY ASSURANCE CON TEDESCO FLUENTE
Locarno, Tessin
Orienta SA
Heute
Job angesehen
Arbeitsbeschreibung
Il nostro cliente, realtà aziendale strutturata operante nel Sopraceneri, ci ha incaricati di selezionare
UN/A QUALITY ASSURANCE CON FLUENTE TEDESCO
Il/La candidato/a ha il compito di supportare il Responsabile del Dipartimento controllo qualità nella gestione delle attività di carattere organizzativo, operativo e burocratico inerente il sistema qualità.
Nello specifico, la risorsa si occuperà di:
- attività legate al controllo dei prodotti
- gestione dei reclami dei clienti
- gestione di documentazione quale: certificati, rapporti di qualità, moduli di controllo
- gestione delle non conformità
- attività amministrative inerenti il sistema qualità
- redigere la documentazione correlata
- collaborare con le altre figure del reparto Controllo Qualità, per ottimizzare i processi aziendali e la qualità dei prodotti
Il/La candidato/a ideale dispone dei seguenti requisiti:
- Formazione tecnica di base
- Familiarità con documentazione tecnica e processi di controllo qualità
- Ottime conoscenze delle lingue italiano , tedesco ed inglese
- Padronanza del pacchetto "MS Office"
Il salario verrà concordato con il candidato finalista.
Branche: Anderes
Funktion: Qualitätsprüfung
Vorgeschlagenes Nettogehalt: Weniger als CHF 500
Führungsperson: Nein
Anstellungsart: Dauerhafte Arbeit
Karrierestufe: Unbefristet
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6
Quality Assurance Specialist (60-80%)
Baar, Zug
Gi Group SA
Vor 20 Tagen gepostet
Job angesehen
Arbeitsbeschreibung
Gi Group SA
Our client, headquartered in Baar, is dedicated to cancer research, developing advanced diagnostics and therapies to improve patient outcomes.
To support their growing team, we are looking for a versatile and motivated QA Specialist and Deputy RP (FvP/QP) to help shape a new and dynamic laboratory environment focused on quality control of generics and nutritional supplements.
In this role, you will play a key part in ensuring regulatory compliance and product quality across several Swiss legal entities.
If you're passionate about software quality, regulatory compliance, and delivering impactful solutions in the life sciences industry, this could be the ideal opportunity for you.
Key Responsibilities include:
- Acting as Deputy QP (FvP), including batch disposition, recalls, and ensuring GDP-compliant
- distribution
- Leading and maintaining the local Quality Management System (QMS) in line with GMP/GDP standards
- Monitoring Out-of-Specification results, deviations, complaints etc.
- Management and scheduling of training
- Conducting management reviews, support with self-inspections, and review of qualification and validation activities on behalf of the RP
- Reviewing analytical methods, specifications, method transfers, method validation, etc. on behalf of the RP
- Assisting and supporting the laboratory team in handling deviations, OOS-results, external complaints and investigations
- Assisting in the laboratory team in setting, changing and approval of product specifications
- Support the Responsible Person with the organization of customer audits and inspections by the authorities
Your Qualifications:
- BSc or MSc in Pharmacy, Chemistry, Biotechnology, or a related field
- Knowledge of Swiss Therapeutic Product Acts and GMP/GDP guidelines
- Several years of experience in GMP/GDP and initial experience in quality assurance within a chemical / pharmaceutical environment
- Validation expertise particularly in the field of equipment qualification, CSV and validation of analytical methods
- Structured and independent personality with a precise and reliable way of working
- Strong analytical mindset with the ability to manage risks, resolve issues, and drive continuous improvement
- Culturally sensitive, enjoy working in international teams and ability to work collaboratively in cross-functional teams
- Excellent communication skills, both written and verbal in English and German
Your Application
Please apply online. For further information about the position, feel free to contact your Gi consultant: Marta Castellano, MSc Biochemistry ( ; +41 76 342 57 90).
Branche: Pharma-Industrie
Funktion: Qualitätsprüfung
Führungsperson: Nein
Anstellungsart: Festanstellung
Leider ist dieser Job in Ihrer Region nicht verfügbar
7
Quality Assurance Specialist (60-80%)
Baar, Zug
Gi Group SA
Vor 21 Tagen gepostet
Job angesehen
Arbeitsbeschreibung
Our client, headquartered in Baar, is dedicated to cancer research, developing advanced diagnostics and therapies to improve patient outcomes.
To support their growing team, we are looking for a versatile and motivated QA Specialist and Deputy RP (FvP/QP) to help shape a new and dynamic laboratory environment focused on quality control of generics and nutritional supplements.
In this role, you will play a key part in ensuring regulatory compliance and product quality across several Swiss legal entities.
If you're passionate about software quality, regulatory compliance, and delivering impactful solutions in the life sciences industry, this could be the ideal opportunity for you.
Key Responsibilities include:
- Acting as Deputy QP (FvP), including batch disposition, recalls, and ensuring GDP-compliant
- distribution
- Leading and maintaining the local Quality Management System (QMS) in line with GMP/GDP standards
- Monitoring Out-of-Specification results, deviations, complaints etc.
- Management and scheduling of training
- Conducting management reviews, support with self-inspections, and review of qualification and validation activities on behalf of the RP
- Reviewing analytical methods, specifications, method transfers, method validation, etc. on behalf of the RP
- Assisting and supporting the laboratory team in handling deviations, OOS-results, external complaints and investigations
- Assisting in the laboratory team in setting, changing and approval of product specifications
- Support the Responsible Person with the organization of customer audits and inspections by the authorities
Your Qualifications:
- BSc or MSc in Pharmacy, Chemistry, Biotechnology, or a related field
- Knowledge of Swiss Therapeutic Product Acts and GMP/GDP guidelines
- Several years of experience in GMP/GDP and initial experience in quality assurance within a chemical / pharmaceutical environment
- Validation expertise particularly in the field of equipment qualification, CSV and validation of analytical methods
- Structured and independent personality with a precise and reliable way of working
- Strong analytical mindset with the ability to manage risks, resolve issues, and drive continuous improvement
- Culturally sensitive, enjoy working in international teams and ability to work collaboratively in cross-functional teams
- Excellent communication skills, both written and verbal in English and German
Your Application
Please apply online. For further information about the position, feel free to contact your Gi consultant: Marta Castellano, MSc Biochemistry ( ; +41 76 342 57 90).
Branche: Pharma-Industrie
Funktion: Qualitätsprüfung
Führungsperson: Nein
Anstellungsart: Festanstellung
Karrierestufe: Angestellte/r
Leider ist dieser Job in Ihrer Region nicht verfügbar
8
Technical Quality Assurance Manager & CSV Expert
Basel, Basel Stadt
Danaher Corporation
Vor 12 Tagen gepostet
Job angesehen
Arbeitsbeschreibung
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Genedata, one of Danaher's ( 15+ operating companies, our work saves lives - and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
The biopharmaceutical industry is undergoing a digitalization revolution, adopting data-driven R&D approaches to develop innovative therapies quicker. Genedata's market-leading enterprise software is fueling this revolution, enabling leading biopharma, biotech, and CRDMO companies worldwide to automate processes and leverage biopharma R&D data analytics so they can find breakthrough therapies faster. Join this digital transformation and help scientists around the world accelerate the pace of biopharma R&D.
Learn about the Danaher Business System ( which makes everything possible.
The Position:
Are you passionate about software quality, regulatory compliance, and delivering impactful solutions in the life sciences industry? Genedata is seeking a Technical Software QA Manager to lead and manage quality assurance activities from a technical perspective for our Genedata Expressionist® Business Unit. In this role, you will ensure that our software meets the highest standards of quality and compliance while supporting successful delivery to customers in regulated environments, noting that this role focuses on defining and ensuring the quality assurance of the developed Expressionist product rather than software development and testing.
You will oversee the continual improvement of our Quality Management System (QMS), manage software validation efforts, and collaborate closely with cross-functional teams throughout the software lifecycle. In addition to internal QA leadership, you will play a key role in supporting pre- and post-sales teams by translating user requirements into compliant, validated software solutions that meet customer needs.
If you have a strong background in software QA, regulations like GxP including 21 CFR Part 11 and predicate rules, and enjoy working at the intersection of science, technology, and customer success, we'd love to hear from you.
Key Responsibilities:
+ Lead and manage all QA activities within the Genedata Expressionist Business Unit, ensuring alignment with regulatory and business objectives
+ Continually improve and maintain effective QMS processes to enhance product quality and operational efficiency
+ Define, review, and maintain software requirements and documentation in compliance with GxP, FDA 21 CFR Part 11, ISO, and other relevant regulations and standards
+ Ensure full traceability from requirements through implementation and testing to support, validation and audit readiness
+ Collaborate with cross-functional teams (Product Management, Development, DevOps, Support) to embed quality throughout the software lifecycle
+ Provide software validation services to customers in regulated environments, including documentation, test protocols, and audit support
+ Act as a subject matter expert on software validation and compliance in both internal and customer-facing contexts
+ Support pre- and post-sales teams in understanding user requirements and ensuring successful software solution roll-out in regulated environments
+ Train internal teams on compliance topics such as GxP, 21 CFR Part 11, GAMP5, and GDPR
+ Facilitate and support internal, customer, and regulatory audits as needed
Your Profile:
+ Experience: 5+ years in software QA, ideally in life sciences software industries
+ Regulatory Knowledge: Strong understanding of GxP, FDA 21 CFR Part 11, ISO 9001, and GAMP5; experience with audit preparation and compliance documentation
+ Compliance-Focused Technical Proficiency: Hands-on experience with software features that support compliance, including electronic records/signatures, audit trails, traceability, and documentation workflows
+ Validation Expertise: Proven ability to deliver software validation services to customers, including system lifecycle documentation, test protocols, and audit support
+ Education: Bachelor's or master's degree in computer science, bioinformatics, or a degree in life sciences with a strong affinity for software/computerized systems validation
+ Cross-Functional Collaboration: Skilled in working with product, development, DevOps, and support teams to embed quality throughout the SDLC
+ Training & Communication: Capable of training teams on compliance topics and representing QA in customer and regulatory interactions
+ Problem-Solving: Strong analytical mindset with the ability to manage risks, resolve issues, and drive continuous improvement
+ Continual Professional Development (CPD): Active CPD to strengthen areas of expertise and develop competencies as an impactful Quality Professional
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Genedata, one of Danaher's ( 15+ operating companies, our work saves lives - and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
The biopharmaceutical industry is undergoing a digitalization revolution, adopting data-driven R&D approaches to develop innovative therapies quicker. Genedata's market-leading enterprise software is fueling this revolution, enabling leading biopharma, biotech, and CRDMO companies worldwide to automate processes and leverage biopharma R&D data analytics so they can find breakthrough therapies faster. Join this digital transformation and help scientists around the world accelerate the pace of biopharma R&D.
Learn about the Danaher Business System ( which makes everything possible.
The Position:
Are you passionate about software quality, regulatory compliance, and delivering impactful solutions in the life sciences industry? Genedata is seeking a Technical Software QA Manager to lead and manage quality assurance activities from a technical perspective for our Genedata Expressionist® Business Unit. In this role, you will ensure that our software meets the highest standards of quality and compliance while supporting successful delivery to customers in regulated environments, noting that this role focuses on defining and ensuring the quality assurance of the developed Expressionist product rather than software development and testing.
You will oversee the continual improvement of our Quality Management System (QMS), manage software validation efforts, and collaborate closely with cross-functional teams throughout the software lifecycle. In addition to internal QA leadership, you will play a key role in supporting pre- and post-sales teams by translating user requirements into compliant, validated software solutions that meet customer needs.
If you have a strong background in software QA, regulations like GxP including 21 CFR Part 11 and predicate rules, and enjoy working at the intersection of science, technology, and customer success, we'd love to hear from you.
Key Responsibilities:
+ Lead and manage all QA activities within the Genedata Expressionist Business Unit, ensuring alignment with regulatory and business objectives
+ Continually improve and maintain effective QMS processes to enhance product quality and operational efficiency
+ Define, review, and maintain software requirements and documentation in compliance with GxP, FDA 21 CFR Part 11, ISO, and other relevant regulations and standards
+ Ensure full traceability from requirements through implementation and testing to support, validation and audit readiness
+ Collaborate with cross-functional teams (Product Management, Development, DevOps, Support) to embed quality throughout the software lifecycle
+ Provide software validation services to customers in regulated environments, including documentation, test protocols, and audit support
+ Act as a subject matter expert on software validation and compliance in both internal and customer-facing contexts
+ Support pre- and post-sales teams in understanding user requirements and ensuring successful software solution roll-out in regulated environments
+ Train internal teams on compliance topics such as GxP, 21 CFR Part 11, GAMP5, and GDPR
+ Facilitate and support internal, customer, and regulatory audits as needed
Your Profile:
+ Experience: 5+ years in software QA, ideally in life sciences software industries
+ Regulatory Knowledge: Strong understanding of GxP, FDA 21 CFR Part 11, ISO 9001, and GAMP5; experience with audit preparation and compliance documentation
+ Compliance-Focused Technical Proficiency: Hands-on experience with software features that support compliance, including electronic records/signatures, audit trails, traceability, and documentation workflows
+ Validation Expertise: Proven ability to deliver software validation services to customers, including system lifecycle documentation, test protocols, and audit support
+ Education: Bachelor's or master's degree in computer science, bioinformatics, or a degree in life sciences with a strong affinity for software/computerized systems validation
+ Cross-Functional Collaboration: Skilled in working with product, development, DevOps, and support teams to embed quality throughout the SDLC
+ Training & Communication: Capable of training teams on compliance topics and representing QA in customer and regulatory interactions
+ Problem-Solving: Strong analytical mindset with the ability to manage risks, resolve issues, and drive continuous improvement
+ Continual Professional Development (CPD): Active CPD to strengthen areas of expertise and develop competencies as an impactful Quality Professional
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
Leider ist dieser Job in Ihrer Region nicht verfügbar
9