Director Quality (m/w/d)

State-of-the-art medical technology in combination with life science systems
Standort Land Branche Referenz
München Deutschland Life Sciences / Pharma, Medizintechnik SF1615

Our mandate is a München based start-up company with a patented, breakthrough technology for fluorescence image-guided surgery, which enables surgeons to detect tumor tissue more accurately and thus remove it with greater precision. The company is a spin-off of Helmholtz Zentrum, München and has already made significant progress in the clinical development of its imagin system (Phase III). Being an idependent part of an international market leader in diagnostic imaging, the company offers both features of working in a start-up atmoshere plus the security and financial strenth of belonging to a peer international organization.

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Ihre Aufgaben

  • 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

Ihr Profil

  • 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
  • Fluent in English

Ihre Chance

  • High level responsibility in an exciting and dynamic environment
  • Fascinating challenge in high-end medicine
  • Be part of the introduction of a breakthrough technology for tumor surgery
  • Be a major part of a small team in an exciting industry
  • Work in a start-up atmosphere with the backgr ound of an international market leader
  • Additional benefits as insurances and pension fund

Haben wir Ihr Interesse geweckt? Dann freuen wir uns, Sie kennen zu lernen!

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Ihre Personalberater

Gerne beantworten wir Ihre Fragen rund um die Stelle und zur Bewerbung:

Bild Siegfried Faix

Siegfried Faix

Managing Partner

T +49 761 888 51 23 10

Bild Peter Majer

Peter Majer

Senior Partner

M +49 172 68 404 58