Director Quality

BESTMINDS GmbH

Später bewerben

We're looking for a candidate to this position in an exciting company.

  • Develops and implements the adequate (GXP, and ISO) Quality System, processes and tools to manage in compliance the operations
  • Ensures all areas of quality systems are compliant with international guidelines and requirements
  • The primary quality approver on design history documents, product specifications and release, labeling materials, deviations, complaints, CAPAs, non-conformances, protocols, reports, OOS and OOT,
  • Quality Lead for product development teams
  • Deploys and implement Corporate Policy and Quality Guidelines as appropriate
  • Leads and performs quality audits, both internal and external, for medical devices and pharma products
  • Ensures regular reporting to Management and Corporate Quality Management
  • Review and edit technical dossiers for Explorer Medical Devices submissions as well as respective documentation pertinent to imaging drugs
  • Research international regulatory and quality requirements and implement necessary changes
  • Primary Quality contact for interactions with all contract manufacturers, sister companies, Corporate Quality Management (CQM), as well as all internal departments within SurgVision
  • Own quality agreements and recall processes
  • Chairs the Change Control Board and Management Reviews to ensure Management involvement and visibility to quality issues
  • Represent in the parent company Corporate Quality Council
  • Lead the Quality Department

  • B.S. in Science, Engineering or equivalent combination of education and experience
  • several years of experience in both Medical Device and Pharma manufacturing environment
  • Medical device / Pharma Quality System auditing skills and certification
  • Experience with quality systems regulations and guidelines, ISO, MDD, 21 CFR Part 11 and other FDA and international reulatory requirements.
  • Drug GMP experience
  • Medical Device experience
  • Quality related expertise in FDA and CE certification processes
  • Drug GCP knowledge is a strong plus
  • Proven track record in quality project management is a plus

Später bewerben

Stellenangebot in: München