Quality Assurance Manager

Il y a 1 semaine

Montpellier, Occitanie, France EPM Scientific Temps plein

Location: Montpellier, France (5 days on-site)

Hours: 40 hours per week (full-time)

Engagement: Freelance

Key Responsibilities

  • Ensure the Quality Management System remains compliant with internal procedures and applicable global regulatory requirements, including ISO 13485, EU MDR, FDA QSR/QMSR, and MDSAP frameworks.
  • Lead the CAPA process from initiation to closure, including investigations, root cause analysis, implementation of corrective actions, effectiveness checks, and ongoing performance monitoring.
  • Manage quality events arising from audits, non-conformities, complaints, supplier issues, and regulatory inspections, ensuring timely and effective resolution.
  • Oversee the Change Control process, coordinating cross-functional assessments, approvals, implementation activities, and associated documentation updates.
  • Maintain and administer the electronic QMS and SharePoint-based quality systems, ensuring accurate records, controlled documentation, and efficient system performance.
  • Partner with cross-functional teams to drive continuous improvement initiatives, maintain inspection readiness, and strengthen overall quality system effectiveness.

Requirements

  • Master\'s degree in Quality Assurance or a related discipline.
  • 5-10 years\' QA experience within the medical device industry.
  • Strong working knowledge of ISO 13485, EU MDR 2017/745, FDA QSR/QMSR, and MDSAP requirements.
  • Hands-on experience with CAPA, Change Control, Document Control, and electronic QMS platforms.
  • Strong stakeholder management, problem-solving, and Microsoft 365/SharePoint skills
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