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Quality Manager

  • Job type: Permanent
  • Location: Munich
  • Salary: Competitive
  • Job reference: KTAE
  • Sector: Quality Assurance, EPM Scientific, Quality
  • Date posted: 02/01/2018
A leading multi-national Medical Device company is seeking an experienced Quality Manager required to direct their Munich office. The Quality Manager will lead a team of four Quality Engineers in supporting Automation & Informatics product lines. He/she ensures compliance with the products and the design process, including design changes to established products.

Company Overview

The company is a market leader in simplifying, automating and innovating biomedical testing. Their diagnostic systems are found in hospitals across the globe. Their life science research instruments are used in studies into complex biological issues. My client’s products have been making a difference in peoples’ lives for 80 years and improve the productivity of medical professionals and scientists, by offering critical information for healthcare improvement and cost reduction.

  • Leads and develops a team of Quality Engineers
  • Ensures Design Control compliance
  • Drives Design Validation and non-product software validation
  • Coordinates Risk Management activities
  • Drives improvement of local and global processes associated with design and development
  • Bachelor/Master degree in sciences, life sciences, engineering, software development or equivalent education gained through work experiences.
  • Experience in leading a team in Medical device OR IVD industry
  • Practical experience of ISO9001, ISO13485 and 21 CFR part 820 Quality System Regulation
  • Experience in design validation simulating end use or actual end use in a clinical environment
  • Knowledge of ISO14971, IEC 60601 / IEC 61010 3rd Edition, IEC 62366 and IEC 62304.
  • Proficient in English
  • Clean driving recordability to travel as required (may include international travel).
  • Travel Expense Cover
  • 30 days holiday (inclusive of bank holidays)
  • Pension plan

Apply here if you are interested in this opportunity or if you would like a confidential discussion about your career opportunities please contact: or phone +442033758277.
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