A senior quality engineer is required to support a post-market team in a hybrid role with a multinational medical device client. The ideal candidate will be directly involved in ensuring the products are maintained throughout their lifecycle, including implementing product/process/materials changes to the manufacturing operation.
The role involves assessing patient risk for design changes, providing QA technical direction/input to qualification and validation activities, and generating design verification protocols.
The successful candidate will participate in compiling design verification and shelf-life data for regulatory submissions to support design change approval, interface with regulatory affairs to ensure clear information presentation, and contribute to establishing strong working relationships across the organization and with partners within a complex technical environment.
Key responsibilities include generating and approving change requests, leading investigation analysis, and timely completion of same
Required Skills and Qualifications: Bachelors Degree (Level 8) in Engineering, Science, or related discipline, 4+ years experience in a design assurance/R&D/Quality role within the Medical Device industry, Strong critical thinking and problem-solving ability, Ability to collaborate effectively within a talented team and work effectively and proactively on cross-functional teams.
Benefits
* Opportunity to work with a multinational medical device client
* Hybrid role with a mix of office and remote work
* 12-month contract with potential for extension
Others
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