CVO / CH / ING / 1042
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 :
Quality Engineer - Medical Devices F / M
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, ),
Handle non conformities, investigations, CAPAs,
Manage and treat customer complaints concerning the quality of products,
Improve the quality management system.
Qualifications / Skills
You have an engineering degree or equivalent by experience.
You have experience in the field of Quality Assurance in the Medical Devices industry.
You have strong 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.
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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