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Head of RA and QA

  • Job type: Permanent
  • Location: Winterthur
  • Salary: Negotiable
  • Job reference: 424103/001_1554379639
  • Sector: Quality Assurance, EPM Scientific
  • Date posted: 04/04/2019

Responsibilities:

  • Leading the QA/RA team
  • Maintenance of the Quality Management System
  • Procedural responsibility for audits, deviations, complaints, CAPAs
  • Supporting risk management
  • Responsibility for Regulatory Affairs, Vigilance Systems
  • Contact for Notified Bodies, National Competent Authorities and Distributors

Requirements:

  • Technical degree, Diploma/Apprenticeship
  • Leadership experience
  • Process management, solid knowledge of ISO 13485, 21CFR 820, MDD 93/42/EEC, MDR 2017/745/EU, MDSAP
  • Fluency in English and German
  • 5+ years in Medical Device

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