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 !