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Quality Manager


  berlin,   75K

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  Quality    Permanent

Vacancy Details

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

Salary: Competitive

 

Responsibilities:

Key Responsibilities

  • 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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