Delivering Excellence in Commercial Projects
We are seeking a Senior Quality Engineer to support our commercial projects from a Design Assurance perspective.
This role involves ensuring our products are maintained through the full product lifecycle and comply with global standards.
The successful candidate will be directly involved in introducing and implementing product/process/materials changes to our manufacturing operation, assessing patient risk for these design changes, and providing QA technical direction/input to qualification and validation activities.
Key responsibilities include generating Design Verification protocols, participating in the compilation of design verification and shelf life data for regulatory submissions, and interfacing with Regulatory Affairs to ensure clear presentation of information.
The ideal candidate will maintain expert knowledge of developments in regulatory compliance requirements and generate and approve change requests.
Additional responsibilities include leading investigation analysis, collaborating with engineering and manufacturing functions to ensure quality standards, designing inspection and testing mechanisms, and conducting statistical analysis.
This is a key role within our organization, requiring collaboration with cross-functional teams, complaints team, and partners in a complex technical environment.