QMS Specialist
QMS Specialist - FREELANCE CONTRACT
Contract Details
Start Date: Immediately
Location: Marseille, France (3 days on-site/2 days remote)
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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