Senior Quality Assurance Officer

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