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Medical Device Development Lead Consultant
vor 1 Woche
We are looking for an experienced Medical Device Development Lead Consultant to join our team at Consultys Suisse.
The successful candidate will have a strong background in quality management, particularly in the medical device industry, and excellent leadership skills.
Key Responsibilities:
- Provide guidance on technical operational QA and general QA matters for specific vendors in design/development and/or testing/manufacturing of medical devices and combination products ensuring application of MDR, ISO and GMP/cGMP requirements.
- Lead and manage Design & Development activities, from Inputs definition through Design Transfer (including Validation/Verification activities)
- Ensure that all Design History Files (DHF) are properly maintained and updated.
- Collaborate with cross-functional teams to ensure effective implementation of quality processes and procedures.
- Develop and maintain relationships with key stakeholders, including vendors and internal teams.
Requirements:
- A minimum of 5 years of experience working in the pharmaceutical/biologics/medical device industry in a quality management position.
- Practical understanding of ISO 13485:2016, MDR, ISO 14971 and 21CFR820 and part 4 requirements.
- Strong leadership and communication skills.
- Ability to work effectively in a cross-cultural team environment.
