Ingenieur Qualite

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

LILMO's quality engineer ensures all operations related to the quality process in order to maintain and enhance the quality system of LILMO.

-Ensure the effective operation of the CAPA management process

-Monitor the action plan with process owners

-Update and monitor KPIs

2. Investigations

-Manage investigations related to customer complaints using the site’s problem-solving tools (8D, 6M, 5 Whys)

-Monitor surveillance plans in accordance with current procedures

4. Others

-Participate in audits (internal, customer, regulatory authorities)

-Assist in the preparation and updating of quality documentation

Profile

-Technical: ISO 13485, Lean and Six Sigma tools

-Methodological: project management, PDCA, KPI monitoring, analytical and synthesis skills

-Managerial: leadership, change management, cross-functional collaboration, coordination, decision-making

-Languages: French and English

Location

Pamplemousses

Minimum level of education required

4- Bac +2/3

Minimum level of experience required

2-5 years

General information

Organisation

Join Vygon and contribute to a mission that makes sense: Value Life.

We design and manufacture top-quality medical devices by guaranteeing through quality control the traceability of our products, from design to distribution. Our group now has the support of 26 subsidiaries and 11 production sites, including 8 in Europe.

Working at Vygon means joining an international group but also an independent, family-owned company. Thanks to the hard work of our 2,619 employees, Vygon manufactures approximately 210 million medical devices each year.

At Vygon, integrity, commitment, open-mindedness, search for improvement and respect for people are at the heart of everything we do.

We are committed to promoting a diverse and inclusive workplace and our recruitment process is designed to ensure equal opportunities for all candidates.