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Archiviertes Projekt - Quality Assurance Manager medical devices

Firmenname für PREMIUM-Mitglieder sichtbar

März 2020

August 2020

CH-Switzerland

auf Anfrage

05.02.2020

CR/102676_1580896555

Projektbeschreibung

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.

Major Accountabilities:

* Write, Review and approve deliverables (e.g. procedures, records, third party work, contractors, clinical trial material, components) and related tools (e.g. 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 (e.g. development of new tools, processes).
* Perform or support inspections and audits as required.
* Write/contribute to internal compliance policy and/or comment to regulations.

Experience:
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.

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