Quality Engineer – Medical Devices, CAPA & Investigations

Vygon France; Élancourt; Sur place; EUR 5 500 - 11 000; Plein temps

Résumé du poste

Vygon France is seeking a Quality Engineer to oversee quality processes, CAPA activities, and investigations. You will monitor KPIs, support audits, and update quality documentation while collaborating with cross-functional teams in a dynamic medical devices environment.

The role emphasizes ISO 13485 alignment, PDCA cycles, and continuous improvement, with English and French language requirements for global coordination.

Qualifications

• Experience with ISO 13485 and quality systems.
• Proven ability in CAPA, investigations and problem solving.
• Strong project management and KPI monitoring skills.
• Excellent cross-functional collaboration and leadership.
• Fluent in French and English.

Responsabilités

• Ensure the effective operation of the CAPA management process.
• Monitor the action plan with process owners.
• Update and monitor KPIs.
• Manage investigations related to customer complaints using tools (8D, 6M, 5 Whys).
• Monitor surveillance plans in accordance with procedures.
• Participate in audits (internal, customer, regulatory authorities).
• Assist in the preparation and updating of quality documentation.

Connaissances

ISO 13485

Lean Six Sigma

PDCA

KPI monitoring

Project management

Leadership

Cross-functional collaboration

Change management

Analytical skills

French

English

Formation

Bac+2/3

Description du poste

Vygon France is seeking a Quality Engineer to oversee quality processes, CAPA activities, and investigations. You will monitor KPIs, support audits, and update quality documentation while collaborating with cross-functional teams in a dynamic medical devices environment.

The role emphasizes ISO 13485 alignment, PDCA cycles, and continuous improvement, with English and French language requirements for global coordination.