Quality Assurance Manager medical devices
Posted on Feb 6, 2020 by Michael Bailey Associates - Zurich
Quality Assurance Manager - medical devices 6 months contract, Basel
My client is looking for experienced QA manager to support technical development and manufacturing operations of assigned Medical Devices/Combination Products.
* Write, Review and approve deliverables (eg procedures, records, third party work, contractors, clinical trial material, components) and related tools (eg IT, document systems, training tools, facility validation) to ensure GMP compliance.
* Accountable for monitoring, analysis and reporting of GMP related KPIs as part of management reporting.
* Release of medical devices for clinical studies and commercial use.
* Support Medical Device Risk Management, through proactive risk management tools and approaches, to minimize impact on global supplies and patients.
* Represent MD Quality in initiatives and cross-divisional projects.
* Lead project related activities (eg development of new tools, processes).
* Perform or support inspections and audits as required.
* Write/contribute to internal compliance policy and/or comment to regulations.
1. At least 5 years of relevant experience.
2. Ability to influence people, negotiate and communicate.
3. Sound scientific, technical and regulatory knowledge in a specific area.
4. Excellent knowledge of cGMP, working knowledge of medical device and combination product regulations, standards and guidelines.
5. Good knowledge of medical device development and life cycle management.
6. Good organizational skills.
7. Good and proven ability to analyse and evaluate GMP compliance.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.