Medical Device Quality Assurance Expert

vor 1 Monat


Hamburg, Hamburg, Deutschland Olympus Vollzeit
Job Description

Olympus is seeking a Medical Device Quality Assurance Expert to join their team. In this role, you will be responsible for negotiating and executing quality assurance agreements with regional suppliers, ensuring compliance with regulatory standards.

Responsibilities:
  • Negotiate, prepare, and execute regional and local quality assurance agreements
  • Collaborate with procurement and supply chain management teams for supplier selection, evaluation, development, and risk management
  • Lead supplier improvement projects
  • Develop and execute the vision and strategy for supplier quality assurance activities in partnership with the Category Manager
Requirements:
  • MSc degree or equivalent in Life Science, Engineering, or equivalent field
  • Demonstrated comprehensive expertise in worldwide regulatory standards and laws applicable to medical devices (e.g., ISO, QSR, GMP)
  • High level of quality tools and methodology skills (e.g., 8D, 5-Whys, FMEA, IQ/OQ/PQ)
  • Adept negotiation and communication skills to foster positive supplier relationships
  • Business fluent in English, conversational German is mandatory, additional European language skills are highly beneficial
  • Certification as Supplier Quality Auditor is required
  • Strong project management skills with ability to lead cross-functional projects
Benefits:
  • 30 days of annual leave
  • Up to 60% mobile work possible + flexible work time model with overtime compensation
  • Holiday and Christmas bonuses
  • Corporate benefits discounts for employees
  • Comprehensive company pension scheme and capital-forming benefits
  • Company restaurant with live cooking and healthy food (subsidized)
  • Employee Assistance Program of FamPLUS to support your health, mental and emotional well-being
  • Subsidy for public transportation (Deutschlandticket), free parking spaces and bike or car leasing

Estimated Salary: €80,000 - €110,000 per annum



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