Quality Assurance Manager

EPM Scientific; Montpellier; Sur place; EUR 60 000 - 120 000; Plein temps

Résumé du poste

EPM Scientific in Montpellier is seeking a freelance Quality Assurance professional to ensure QMS compliance with ISO 13485 and EU MDR standards. You will lead CAPA from investigation to closure, manage quality events, and oversee Change Control processes across cross-functional teams.

The role requires 5–10 years in the medical device QA domain, strong document control experience, and hands-on use of electronic QMS platforms and SharePoint.

Qualifications

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

Responsabilités

• Maintain and ensure QMS compliance with internal procedures and global regulations.
• Lead CAPA investigations from initiation to closure and effectiveness checks.
• Manage quality events from audits, non-conformities, complaints, and inspections.
• Oversee Change Control processes with cross-functional approvals and documentation.
• Maintain electronic QMS and SharePoint-based systems with accurate records.
• Collaborate cross-functionally to drive continuous quality improvements and inspection readiness.

Connaissances

Quality Assurance

Regulatory compliance

CAPA

Change Control

Document Control

Microsoft 365

Stakeholder management

Investigations

Root cause analysis

MS SharePoint

Formation

Master's degree in Quality Assurance

Outils

SharePoint

QMS software

Description du poste

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