Global Market Entry - Innovative Medical Device
Our customer is an innovative Nasdaq-listed pharmaceutical and device company. A thrilling new product classified as medical device will be launched shortly. In this context, we are looking for a committed and independent professional to join our rapidly growing team as Senior Quality Assurance Manager with excellent specialist knowledge.
- Manage all QA matters related to medical devices, including the definition and implementation of QA strategies
- Prepare for transition from Cl. I to Cl. IIa in Europe under MDR, incl. conformity assessment by notified body
- Develop / expand existing GxP Quality System, set up for pharmaceuticals, to align with medical device specific requirements, including supervision of quality documents, as well as related implementation and training
- Ensure high quality of all product related activities and documents in accordance with SOPs and GxP requirements, respectively
- Support medical device ESPs (e.g., suppliers, CROs) as regards development and implementation of quality assurance standards in accordance with GxP requirements
- Ensure medical device readiness for audits / inspections, manage audits / inspections and handle responses to findings
You will monitor change control and CAPA processes, create appropriate documentation and train your colleagues on all relevant GxP topics. You will provide adequate support to internal departments as regards QA compliance of medical devices and have the lead in projects requiring specific QA subject matter expert knowledge.
- Technical or scientific university degree
- + 7-10 years of in-depth QA experience in medical devices (class I-II)
- QA interface with R&D, CRO, Suppliers, and CMO partners
- QA responsibility for medical devices commercialised in various regions/markets
- Effective and adept management of change control and CAPA process
- Audit and inspection management with notified bodies and authorities
- Excellent command of written and oral English
Your autonomy, your integrity, and your initiative are of particular value. Your service-oriented approach will be of help to liaise with all internal and external stakeholders involved. Join us as the next reliable team member in this familial work environment. Working place is close to Basel SBB train station.
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