To strengthen our team in Switzerland we are looking for a Quality Assurance Engineer specialized in Medical Device.
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.
- Act as quality management representative in project teams.
- Lead dedicated team efforts, e.g. regulatory submissions preparation, root cause analysis, new regulation/standard task force.
- Cooperate with team members on a continuous basis through document review.
- Be an active team member, promote quality initiatives.
- Collaborate actively on the development of combination products and on design transfers.
- Ensure continued alignment with Regulatory Affairs teams (global and local) requirements and planning.
- Ensure continued alignment with Legal teams (global and local) requirements, strategies and planning.
- Collaborate actively on selection of suppliers and establishment of contractual documents.
- Ensure direct and continued contact with supplier teams through team meetings and document review.
Master or Engineering Degree in quality engineering (EPFL, ETH, HES or equivalent).
- Min 5 years of experience as QA/RA manager in the medical devices industry (focus on complex medical electrical equipment, including HW, SW and mechanics) with crossfunctional experience in international environment.
- Strong experience in matter of quality assurance/regulatory affairs (class I, IIB).
- Excellent knowledge of ISO13485, 21 CFR 820, ISO 14971.
- Excellent knowledge of medical device regulations, CE marking, 510 (k), 21 CFR 4 for combination products.
- Knowledge of electrical and software development standards (IEC 60601-1, IEC 62304) and of the radio-communication regulations (1999/9/EC, 47 CFR) is a plus.
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.
We are looking forward to meeting you very soon at Altran!