A new and exciting role has arisen for a highly experienced Quality Engineer to join a Medical Device company in Hampshire and take responsibility leading Concept Feasibility Control, Design Control and Risk Management activities. This role will have an impact across R&D and manufacturing to ensure that all new products and processes meet the relevant regulatory requirements.
Senior R&D Quality Engineer Responsibilities
- Managing quality procedures across R&D and manufacturing ensuring that they adhere to ISO13485, ISO14971, CFR21 Part 820, MDR etc.
- Oversight and review of concept feasibility control and design control documentation throughout product and process development
- Lead QMS remediation efforts
- Write and review relevant validation documentation
- Performing internal and external audits
- Degree or equivalent in Science or Engineering
- A strong background in Medical Device Quality and knowledge of ISO13485, ISO14971, CFR21 Part 820, MDR etc
- Experience in end to end product development from concept feasibility through development and manufacturing
- A strong communicator able to work in cross functional teams