Quality Assurance Engineer

Responsibilities

• Ensure compliance with ISO 13485, FDA 21 CFR 820, EU MDR, and other regulatory requirements
• Support internal, external, and customer audits by preparing documentation and leading follow-up activities
• Provide quality engineering support for manufacturing processes including molding, assembly, and packaging
• Oversee process validations (IQ, OQ, PQ) and maintain all necessary validation documentation
• Participate in PFMEA, Control Plans, and risk management activities
• Lead root cause investigations using tools such as 8D, Fishbone, and 5-Why
• Implement and verify the effectiveness of corrective and preventive actions (CAPA)
• Support New Product Introduction (NPI) through quality planning and risk assessments
• Investigate customer complaints and collaborate with customers to resolve quality issues

Requirements

• Bachelor’s degree in Engineering, Quality, Science, or a related discipline
• 2–5+ years of quality engineering experience in a regulated manufacturing environment (medical device, pharmaceutical, or healthcare packaging preferred)
• Strong knowledge of ISO 13485, FDA 21 CFR 820, and Risk Management (ISO 14971)
• Expertise in process validation and statistical tools/SPC
• Proficiency in MS Office

About the Company

Datwyler is a high-tech company specializing in high-quality, system-critical elastomer components. We serve global markets including healthcare, mobility, connectivity, and food & beverage. With over 25 production sites worldwide and 8,000 employees, we are committed to patient safety and product excellence through innovation and continuous improvement.