Quality Control Technician

Versa Vascular is an innovative medical device startup developing next-generation implantable solutions for the treatment of tricuspid heart valve disease. Our mission is to improve patient outcomes through precision engineering, rigorous quality standards, and collaborative innovation. We are seeking a detail-oriented Quality Control Technician to support in-process and final inspection of finished devices, labeling inspections, incoming inspection of purchased materials, and reviewing and filing quality records inspection. This role is essential to ensuring our products meet rigorous regulatory, quality system, and performance requirements while supporting rapid development in a collaborative startup environment. Clean Room/Production responsibilities include: - Perform in-process quality inspections of implantable medical devices and delivery systems to ensure compliance with specifications and quality standards. - Verify and reconcile product labels for accuracy, completeness, and traceability. - Execute established test methods to assess product functionality and verify conformance to performance requirements. - Identify, document, and segregate nonconforming product, promptly communicating findings to the engineering team for evaluation and disposition. - Maintain adherence to clean room protocols, Good Manufacturing Practices (GMP), and all applicable quality system regulations. IQC responsibilities include: - Conduct thorough visual and dimensional inspections of incoming materials, components, and associated documentation to verify compliance with specifications and quality standards. - Utilize appropriate measuring instruments, including Keyence measurement, visual systems, and hand tools to perform accurate inspections. - Record, analyze, and maintain inspection data and quality records in accordance with acceptance criteria. - Follow established sampling plans, inspection procedures, and Good Documentation Practices (GDP) to ensure consistency and traceability. - Identify, document, and segregate nonconforming materials; escalate quality issues to appropriate stakeholders for resolution. - Maintain organized inspection records and support continuous improvement of inspection processes. Other quality responsibilities include: - Review quality documents (Device History Records, Nonconforming Reports, Calibration reports, Manufacturing records, etc) for completeness and compliance to procedures. - File and maintain quality records.