To strengthen our team in Switzerland we are looking for a Quality Assurance / Regulatory Affairs Engineer for Medical Device indutry.
As a consultant you will provide our clients with the necessary expertise and assistance to further improve and maintain the quality standards for their operations and products in the Medical Device industry.
QA-RA Medical Device Engineer
Education level: Master or Engineering Degree in quality engineering (EPFL, ETH, HES or equivalent).
- Min 8 years of experience as QA/RA manager in the medical devices industry (focus on complex medical electrical equipment, including HW, SW and mechanics) with cross-functional experience in international environment.
- Strong experience in matter of quality assurance/regulatory affairs (class I, IIB).
- Knowledge and working experience of quality management system, standards and government regulations applicable to medical devices e.g. ISO 13485, 21 CFR 820 QSR, MDD 93/42/EEC.
- Strong experience in the product development process, risk management and in the compliance process (relationship with external testing houses and agencies/notifies body).
- Strong experience in Management of the CAPA process and PMS (complaints, vigilance and Reporting, FSCA), root cause analysis and HHE.
Languages: French and English.
- You know how to take initiative
- You like to work in a multidisciplinary team
- You value knowledge-sharing
- You must have strong verbal and writing communication capabilities.
Ready to join?
We offer an exciting tailored career path for your professional and personal development within an international company. You will be accompanied from the beginning with specific coaching and mentoring programs and intensive training on innovation and management in a fast-moving and results driven environment.