Qualification/Validation Engineer - Medical Devices
CVO-Europe SA — Cointrin
12.09.2019 | Employee | 100%

Since 1995, CVO-EUROPE’s multidisciplinary team has been supporting life science companies at every stage (design, validation, operation, digital transformation) of critical activities that may affect product quality, data integrity and patient health, whilst ensuring the compliance of their systems, equipment, processes and data.

With its comprehensive service range (consulting, shared service center, auditing, and instructional engineering), the CVO-EUROPE Group is committed to bringing its clients effective and innovative solutions whilst staying true to the human values that have characterized it from the outset.

 

To support our development, we are looking for a:

 

Qualification/Validation Engineer - Medical Devices

 

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 supervise validation activities,
  • Improve the quality management system.

 

Qualification/Skills:

  • You have an engineering degree or equivalent by experience.
  • You have experience in the qualification field and master the IQ/OQ/PQ 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 and 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 personalized career management.

 

If you are looking for a satisfying career, full of rewarding and varied experiences with the possibility for development, apply to join the team at CVO-EUROPE!

 

 

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