Part-Time Quality & Design Assurance Specialist (2 days/week) – Class III Medical Device
As a consulting company specialized in medical devices, we are currently looking for a Quality & Design Assurance Consultant to support one of our clients developing an innovative Class III medical device, currently in design change and clinical investigation phase.
This mission is ideal for a senior QA/RA profile who enjoys working hands-on in R&D environments and collaborating closely with engineering teams.
You will support the client on a variety of Quality and Design topics, including:
* Component management for the console (internal production)
* Internal inspections and continuous improvement of existing practices
* Non-conformities management and CAPA plans:
* Audit-related NC
* Process improvement NC
* Incoming inspection & assembly NC (console)
* Contribution to Design History File / Technical Documentation updates:
* Testing related to design changes
* Verification & Validation activities
* Risk management updates
* Biocompatibility documentation
You will work directly on-site with the engineering team in a highly dynamic development context.
Profile we are looking for :
* Strong experience with Class III medical devices
* Solid expertise in Design Control, DHF, V&V, Risk Management
* Comfortable in design change / R&D environments
* Hands-on mindset, able to collaborate closely with engineers
* Experience with internal manufacturing is a plus
* Autonomous, pragmatic, and improvement-oriented
Position to be filled ASAP
Join us for an owl-some collaboration !