- Responsible for maintaining the design control activities associated with the Medical Device portfolio.
- Ensure Design History Files are in compliance to the latest Quality and Regulatory requirements.
- Assess change controls for impact to Product Design History Files & Design Verification.
- Support sustaining commercial projects from a Design Assurance perspective.
- Be involved in making sure products are maintained through the full product lifecycle and that these products comply with global standards.
- Support the introduction/implementation of product/process/materials changes to the manufacturing operation.
- Assess the risk appropriately for these design changes.
- Provide QA technical direction/input to qualification and validation activities in conjunction with Mfg. Engineering.
- Responsible for generation and completion of Design Verification protocols & design verification reports.
- University degree in a Science or Engineering related discipline
- 3-5+ years of experience in design assurance, new product development or related medical device experience
- Self-starter and independent critical thinker, with the aptitude to work autonomously and within a team
- Strong interpersonal, organizational, and project management skills
- Demonstrated use of Quality tools/methodologies.
For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email firstname.lastname@example.org