My client, a leading Medtech based in Baden-Württemberg are looking for a Quality manager . A great opportunity to join a fast growing business with a large product portfolio.
Title: Quality Manager
- Promote the general understanding for and the acceptance of quality requirements within the company’s R&D group by devising and conducting regular trainings and workshops and coaching individual members of the group if needed
- Provide QMsupport to R&D and OEM projects and act as the main quality contact within OEM projects
- Plan, implement and advance the company’s quality system according to ISO 13485, FDA QSR, ANVISA RDC 16/2013 and other international regulatory requirements specifically within the context of R&D processes
- Set up and negotiate quality agreements with OEM customers
- Review R&D documents for QM compliance
- Issue nonconformity reports, conduct root cause analyses and define and implement CAPAs
- Perform gap analyses on new or updated regulatory requirements and subsequently develop project plans for closing of any identified gaps specifically within the context of R&D processes and OEM projects
- Create and regularly update key quality documents such as quality manual, SOPs etc.
- Plan and conduct internal audits
- Organize and accompany audits by OEM customers and handle followup tasks
- Assist in preparation of and accompany audits by Notified Bodies and regulatory bodies
- Assist in general communication with Notified Bodies, regulatory bodies, customers and suppliers
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