We are a market leading Medical Device Manufacturer and due to our continued exceptional growth, we have an exciting opportunity for an NPI Quality Engineer to join the team.
As our new NPI Quality Engineer you will support and deliver a range of Quality Engineering activities with a focus on NPI programmes. You will support and take ownership for the requirements through the design and development process working cross functionally to understand, plan and execute the design and development stages.
- To identify, define and deliver all Quality Engineering deliverables to ensure product quality and compliance, within agreed cost and timelines ensuring compliance with external standards (eg ISO 13485 and 21 CRF part 820
- Ensure Risk Management and Validation activities are completed and updated effectively. Conduct independent document reviews and approvals to ensure compliance with input documents including Usability/Human Factors, ISO 10993 testing, ISO 14971, IEC 62366, reliability requirements and Essential Performance Requirements (EPR’s)
- Review and agree the release of NPI products based on their usage (development testing, clinical trials, verification, validation etc.), ensuring they are according to the customer requirements and are compliant to the applicable regulations
- Generation of documentation (as either Author, reviewer, approver) that ensure programme/product is compliant through the NPI stages of development. Including documentation required for the Design History File and Regulatory submissions
Experience, Education and Knowledge Required:
- Proven experience within a Medical Device and/or IVD Manufacturing Environment
- Knowledge and application of design control, risk management requirements for medical device/combination products
- Exposure to or experience in working with Six Sigma tools/methodology.
- Good working knowledge of ISO 13485, 21 CRF Part 820, ISO 14971, ISO 10993, GMP, European Medical Device Regulation, QSIT.
If you have the necessary skills and experience to be successful in this role, please apply now or contact Kris Holmes on 01189 239 234.
Permanent, Full Time
Additional Salary Info
- Industry Sector Engineering, Utilities