Quality Engineer Manufacturing

About ARTIDISARTIDIS AG is a clinical-stage health-tech start-up founded in Basel, Switzerland, that has developed the first nanomechanical biomarker for cancer diagnosis and treatment optimization. The ARTIDIS nanotechnology platform integrates different types of clinical data into the ARTIDISNET digital platform, allowing physicians to significantly shorten the current diagnostic process and benefit both the patient and the healthcare system. ARTIDIS enables professionals to design personalized cancer treatment plans tailored to individual patients' needs and desired outcomes. Job PurposeThe role of Quality Engineer and Quality Control is pivotal in ensuring the safety and performance of medical devices and consumables at ARTIDIS throughout the manufacturing process. This position combines engineering expertise with meticulous quality control measures to uphold product excellence and regulatory compliance and demands a person that is equally skilled at the development and hands-on execution of quality control procedures for manufacturing. This role demands a candidate who possesses a combination of engineering knowledge and quality control expertise to ensure the highest standards of product quality and compliance within the dynamic environment of medical device manufacturing. Duties and ResponsibilitiesCollaborate with engineering and production teams to implement a production process for a novel In vitro diagnostic device Plan, supervise and report process validations Participate in the validation of equipment, processes, and software used in the manufacturing of medical devices. Responsible to establish the required documents for infrastructure quality and maintenance of the qualification status Perform process risk assessments and contribute to risk management activities to minimize quality-related risks in the manufacturing process. Establish and maintain quality documentation, including reports, records, and procedures, ensuring completeness and accuracy. Develop and implement quality control procedures, protocols, and inspection plans Conduct inspections on, components, and finished products to ensure conformity to established quality standards and specifications. Analyze production processes to identify opportunities for quality improvements and efficiency enhancements. address quality-related issues, identify root causes, and implement corrective and preventive actions. Hands-on execution of quality control procedures such as assembly and release testing. Train production staff on quality control procedures, standards, and best practices to maintain a culture of quality awareness. QualificationsBachelor's degree in Engineering, Quality Assurance, or a related field; advanced degree preferred. 5+ years proven experience in quality engineering and quality control within the medical device or pharmaceutical manufacturing industry. In-depth understanding of quality management systems, regulatory requirements, and standards (21 CFR 820, ISO 13485, ISO 14971 IVDR, MDR, etc.). Proven experience in planning, coordinating moderating risk analysis teams Strong analytical and problem-solving skills to identify quality issues and implement effective solutions. Proficiency in quality methodologies, such as root cause analysis statistical analysis, FMEA, Six Sigma, or Lean principles. Excellent communication skills to collaborate across departments and effectively convey quality-related information. Detail-oriented with a focus on accuracy in documentation and adherence to quality procedures. Ability to lead and support cross-functional teams in resolving quality-related challenges and driving continuous improvement initiatives. Experience with validation processes for equipment, software, and manufacturing processes is required. Working ConditionsThe environment is a typical start-up with an intrinsically motivated international team. Our company is an excellent place for rapid advancement and offers a promising opportunity to learn and share know-how in a very agile environment. The position requires the employee to go the extra mile when needed. We are looking for a team player who appreciates direct communication. The effort is rewarded with challenging tasks, the possibility to take responsibility, a highly driven team, and work serving a significant purpose. The job position comes with a competitive salary and a bonus for outstanding performance. Full-Time