Snr Quality Engineer, New Product Development
A vacancy has been announced for a Senior Quality Engineer with a global technology company entering the medical device industry. The position based in Switzerland, is offering an exciting opportunity to join an innovative and entrepreneurial organisation to provide expertise and further develop a career in the medical sector.
- Acting as a Subject Matter Expert on quality engineering functions during regulatory audits / inspections
- Supports the corrective / preventive action program by applying root cause analysis and problem solving techniques and by implementing corrective/preventive actions
- Supports the execution of the process qualification and validation activities (IQ, Ranging studies, OQ and PQ) by reviewing protocols/reports
- Performs statistical analysis to determine design acceptance, process capability and analyze trends
- Supports development of appropriate product/component specifications and leads the component qualification activities
- Develops/reviews and approves test method validation protocols and reports
- Supports development of inspection test methods.
- Leads generation, updates, maintains and approves risk management documentation / FMEAs / HHA
- Develops and executes design verification and validations plans, reviews/approves design verification and validation protocols/reports
- Ensures compliance to quality system requirements as defined by internal procedures, FDA QSR, and applicable international standards (e.g. ISO, MDR, ASTM)
- Responsible for supporting all quality engineering activities to support the development of new products (NPD) from concept through commercialisation as part of a cross functional development team
Skills and Requirements
- Bachelor degree in an Engineering discipline, preferably Mechanical Engineering, process engineering, material sciences, chemical or pharmaceutical engineering
- Working knowledge of appropriate global medical devices regulation and standards, such as ISO 13485, ISO 14971, European Medical Device Regulation
- Min. 5 years' experience in medical device industry, or similar regulated industrial environment, with good working knowledge of regulatory requirements and Quality Systems
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.