Qualification / Validation Engineer

Responsibilities

Your main tasks will be (not exhaustive list) to:
• Update, review and approve quality documents (protocols, operating procedures, templates, …) to ensure compliance with applicable standards and regulations (ISO 13485, MDR 2017/745, …),
• Update technical files (biocompatibility assessment, risk analysis, clinical evaluation, …),
• Write the validation documentation (specifications, validation plan, risk analysis, traceability matrix, …)
• Write protocols and validation reports (IQ/OQ/PQ),
• Perform risk assessments (FMEA),
• Perform and/or supervision of validation activities,
• Improve the quality management system.

Qualifications/Skills

• You have an engineering degree or equivalent by experience.
• You have experience in the qualification field and master the QI/QO/QP validation process.
• You have good knowledge of the regulatory requirements related to medical devices (ISO 13485, MDR 2017/745, …).
• You speak fluently French and English.
• You have strong communication skills and an analytical thinking.
• Your social skills enable you to work in team; you are an autonomous person on your activities.

We offer:
- The opportunity to develop your career within a people-oriented group operating at an international level, with the scope to get involved with challenging projects.
- Approachable management and a strong company culture that focuses on professional and personal fulfilment.
- A wide range of career development opportunities.
- Continuing professional development and personalised career management.

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