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Senior Verification
4 months ago
- Lead the planning of verification activities for the system, including both the Instrument and test consumable.
- Ensure tests are designed in alignment with product requirements will full traceability.
- Adhere to the requirements of working in an ISO 13485/FDA regulated environment.
- Implement verification and validation test plans and protocols for the system/product, documenting all activities within the Quality Management System (eQMS).
- Collaborate with the Engineering and quality departments to ensure test method, equipment and materials are available in line with company timelines.
- Analyse and interpret data with precision and contribute to design reviews and collaborative discussions.
- An Engineering degree or equivalent hands-on experience.
- Recent and relevant practical experience in verification of In Vitro Diagnostic (IVD) devices or medical devices in an ISO13485/21CFR regulated environment.
- Experience in writing, editing, or addressing product requirements.
- Proficiency in both Mechanical and Electrical Engineering disciplines.
- Track record of submitting regulated product approval packages, as a minimum under CE-IVD/IVDR, ideally under FDA 21CFR.
- Familiarity with operating within formal documentation systems, ideally under an eQMS.