Ambitious Quality Assurance Professional Sought

Overview We are seeking a highly skilled and experienced Quality Assurance professional to join our team. As a key member of the organization, you will play a vital role in ensuring the quality and compliance of our products.

Responsibilities Maintain and improve quality system documentation processes and procedures

Investigate and resolve quality issues, implementing corrective and preventive actions to mitigate recurrence

Support regulatory submissions for market authorization and coordinate the preparation of software technical documents

Facilitate approval processes for software releases and disseminate knowledge about the Quality System and regulatory requirements

Oversee post-market surveillance activities related to medical device products

Requirements Minimum 5 years' experience in Quality Assurance or Regulatory related fields

Deep understanding of medical device international regulations and related standards (ISO 13485, ISO 14971)

Knowledge and experience working in Medical device software life cycle process (IEC 62304) and medical device regulatory submissions (MDR / IVDR, FDA)

Good level of Technical and Conversational English

What We Offer A meaningful project that will impact the quality of laboratory software medicine worldwide

Opportunities for professional development and growth

Ongoing training and support

Social benefits : Canteen, nursery check, English training

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