With already 32,000 consultants around the world and revenues of CHF. 2,2 Bn. Altran Group is already the global leader in innovation and high-tech engineering consulting.
In Switzerland, Altran employs more than 250 consultants and aims towards large growth. We operate particularly in Life Sciences (Pharma, Biotech, and Medical Devices), in Zürich, Basel.
Quality Assurance - Medical Devices F/M
- A permanent contract with the leader in innovation and high-tech engineering consulting
- A multi-stage model with career opportunities through specialization prospects, as well as through continuing professional education and training
- A steep learning curve due to diverse and cross-industrial project opportunities
- An open and constructive corporate culture with over 31,000 colleagues in over 20 countries.
- Helping clients to realize ideas from ideation, prototyping, industrialization of products, manufacturing, scale-up, distribution as well as service provisioning/support
- Global projects & global job opportunities
- Be aware about new Medical Devices Regulations 'MDR'
- 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.
- 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.
- PhD, Master Degree in Pharmacist or in Quality Engineering
- 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 : English fluent & German is clearly a plus
Mr Maxime Kapps