Device Quality Manager

at  Trasis

As Device Quality Manager, you ensure that equipment complies with applicable legal and regulatory standards. You ensure that products are safe, effective and compliant with requirements for market access and/or maintenance. As Manager of the QA & RA Device department, you define strategic missions in line with the company’s overall strategy and Quality Corporate, and ensure the efficiency of quality operations.

• You participate in the company’s quality/regulatory strategy in each of its areas of equipment use.
• You organize the QA & RA medical device/equipment department and define the associated strategic missions.
• You draw up objectives (quality, regulatory and operational) and ensure their effective implementation.
• You motivate, federate and manage the department. You ensure the implementation of performance indicators (KPIs) to manage and coordinate the department’s activities.
• You maintain an overview of the market’s QA & RA needs to support internal product development.
• You are in charge of regulatory watch.
• You provide advice to sales departments on the global regulatory landscape impacting medical equipment and devices, and define a go-to-market strategy.
• You coordinate the drafting of CE marking dossiers and the life-cycle management of CE marking dossiers, as well as the maintenance of these authorizations.
• You ensure that subcontractors’ regulatory files are properly updated.
• You are the point of contact with health authorities/notified bodies concerning medical devices (distribution, manufacturing, etc.).
• You represent Trasis’ strategic interests in various working groups relating to medical devices and equipment (IEC,…