Quality Engineer (Medical Devices)

AMMGroup; Valbonne; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

A leading MedTech company in Valbonne is searching for a Quality Assurance Specialist. The role involves reviewing and validating compliance documentation, supporting project teams to meet quality standards, and collaborating with cross-functional teams. Required qualifications include extensive experience in Medical Devices, strong knowledge of ISO 13485 and IEC 60601 standards, and excellent English proficiency. Ideal candidates will have strong communication and leadership skills. This is a full-time position.

Responsabilités

• Review and validate all project/product documentation to ensure compliance with QMS and standards.
• Support and coach project teams to meet quality and regulatory requirements.
• Approve deliverables as QA representative.
• Collaborate with cross-functional teams to resolve quality or regulatory issues.
• Identify, assess, and manage risks related to safety, quality, and compliance.
• Analyse non-conformities and follow up CAPA actions.

Connaissances

Solid experience in Medical Devices or Electromedical Products

Strong knowledge of ISO 13485 and IEC 60601 standards

Good understanding of Quality Management Systems

Experience in or exposure to Quality Audits

Ability to review and validate technical documentation

Experience collaborating with R&D teams

Excellent English level

Strong communication coaching and leadership skills

Outils

Minitab

Root cause Analysis

Description du poste

Key Requirements

• Solid experience in Medical Devices (DM) or Electromedical Products
• Strong knowledge of ISO 13485 and IEC 60601 standards
• Good understanding of Quality Management Systems (QMS)
• Experience in or exposure to Quality Audits (internal / external)
• Ability to review and validate technical documentation for compliance
• Experience collaborating with R&D teams on design and product quality
• Excellent English level (American company all documentation and meetings in English)
• Strong communication coaching and leadership skills

Responsibilities

• Review and validate all project / product documentation to ensure compliance with QMS and standards (ISO 13485 / IEC 60601)
• Support and coach project teams to meet quality and regulatory requirements
• Approve deliverables as QA representative
• Collaborate with cross-functional teams to resolve quality or regulatory issues
• Identify assess and manage risks related to safety quality and compliance
• Analyse non-conformities define and follow up CAPA actions

Key Skills

APQP, Quality Assurance, Six Sigma, ISO 9001, PPAP, Minitab, Root cause Analysis, ISO 13485, Quality Systems, Quality Management, As9100, Manufacturing

Employment Type: Full Time

Experience: years

Vacancy: 1