Vitestro is a medical device company pioneering the future of blood collection with the Aletta Autonomous Robotic Phlebotomy Device. As a Senior Quality Assurance Officer, you will play a crucial role in ensuring compliance with laws, regulations, and standards within operations and product development, focusing on Medical Devices manufacturing.
Requirements
- Minimum 3 to 5 years experience in Quality Assurance for medical devices, preferably in a hardware-software environment
- Strong experience working within an ISO13485 Quality Management System
- Hands-on experience with verification and validation activities, including writing and executing test protocols
- Experience with validation of production workflows
- Experience with MDSAP is nice-to-have
- Experience with equipment and process qualification activities (IQ, OQ, PQ)
- Familiarity with software validation or automated testing is an advantage
- Strong technical writing skills for test protocols, validation reports, CAPA documentation, and engineering change records
- Strong analytical mindset with the ability to interpret test results, assess failures, and propose corrective actions
- Strong project management skills, especially coordinating validation activities across engineering, production, and suppliers
- Comfortable working with engineering drawings, CAD files, and technical documentation
- Bachelor’s degree or higher in engineering, applied sciences, biomedical engineering, or similar technical field
Benefits
- Competitive salary including pension plan
- 25 days of annual leave based on a full-time position
- Stock options, to become ‘co-owner’ of a fast-growing company
- Hybrid work model
- Working together in a high-skilled team with our home base in Utrecht
- Frequent out-of-work activities with our team (such as our Skitestro ski-trip)
- Training budget
- Opportunity to be key shaper of a new global industry niche: autonomous medical robotics