Senior R&D Quality Engineer - Medical Device / England

Senior R&D Quality Engineer - Medical Device - Hampshire

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

Senior R&D Quality Engineer Requirements

• 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

If you feel you would be suitable please apply now. A member of the team will be in touch with all relevant applicants