Senior Quality Engineer

THORATEC Switzerland GmbH is part of the medical device division of ABBOTT LABORATORIES, a fortune 500 company with over 110’000 employees worldwide. We are the global market leader for implantable and extracorporeal blood pump systems based on magnetic bearings. Our lifesaving medical devices, which are developed and produced on-site in Zurich, are used for the short- and long-term treatment of patients suffering from severe heart disease.Our location in the heart of the city of Zurich has around 130 employees in the areas of development and production of the CENTRIMAG system and the HEARTMATE 3. Currently, we are expanding our innovative and high-caliber manufacturing engineering team in Zurich and an exciting opportunity exists for a motivated and talented:Senior Quality EngineerWhat You'll DoImplement aspects of the production quality assurance and document control activities to ensure compliance with internal procedures and, if applicable, international regulations.Executes the activities of the quality organization with responsibility for results in terms of product quality, performance, and safety.Responsible for providing support and communication with Operations and Manufacturing Engineering to resolve quality issues and other related product concerns.Actively drives all assigned Quality Systems goals and objectives at the plant level.Work closely with Manufacturing Engineering on Process Validations, Non-Product Software Validation and Qualification of EquipmentDuties and ResponsibilitiesQuality Analysis and Reporting. Analyzes and reports quality metrics and trends for key quality indicators to assist company management in decision-making process.Non-conforming Product.Oversees the evaluation and disposition of non-conforming products and processes identified during production or other quality-relevant processes. Analyzes and resolves and/or escalates issues in a timely fashion. Involves suppliers if cause can be assigned to supplier issues. Coordinates corrective actions with suppliers.Corrective and Preventive Actions. Participates in the analysis of systematic trends related to non-conforming products or processes from internal customers (production) to determine root causes, and if need be, corrective and preventive actions.Validations and Qualifications. Participates in DHF review and document release related to products, tools, and processes. Ensures rationales and applies statistical techniques to guarantee compliance with regulations.General.Travel for company business or training purposes.Performs other administrative duties as assigned by the Manager of Quality Assurance (Zürich facility).Other tasks that are assigned by the Manager of Quality Engineering.Your ProfileBachelor or Master degree in Science, Engineering, or other technical field is required (Fachhochschule or University).Four (4) years of experience in a medical-device manufacturing environment or other FDA/ISO regulated industry in a quality-related role desirable.Familiarity and understanding of international and domestic medical-device regulatory guidelines desirable.Strong communication skills, especially in German and English (written and spoken)Excellent organizational, time management, and multitasking skills.Ability to work in a team environment using effective interpersonal and negotiation skills.Proficiency with personal computers, and technical software.Developed problem solving and decision-making skills.Do you have what it takes? Then send us your application today. We are looking forward to meeting you in the heart of Zurich!Connect with us at , on LinkedIn at , on Facebook at  and on Twitter @AbbottNews and @AbbottGlobal.Job SummaryJob number: 31058010Date posted : 2023-05-25Profession: QualityEmployment type: Full time