We produce Cameras, Insufflators, Medical Pumps, and tubing that makes diagnosis and treatment easier for everyone. As Design Assurance Engineer you are responsible for creation of an overall quality plan, review of design verification and validation specifications, test specifications and reports for medical devices (devices and consumables), review of Design Control documents according to GDP, MDR 2017/CFR820 and leading/contributing to risk management, FMEA and other quality (assurance) related tasks within product development. * Review of design verification and validation test specification for medical devices (equipment and consumables) Involvement in the preparation of test specifications and test requirements for the series testing of medical devices * Experience with product quality in a highly regulated industry (medical device, automotive, aviation etc.)
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