Job DescriptionSenior R&D Quality Engineer - Medical Device - Galway - Permanent
A new and exciting role has arisen for a highly experienced Quality Engineer with a background in Design Assurance to join a Medical Device company in Galway. Supporting the company's product development and commercialisation strategy, this is a high impact role with strong opportunities for progression.
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
- Drive the risk management activities for designated projects and design changes
- Write and review relevant validation documentation
- Develop and maintain design verification and validation plans, protocols and reports.
- 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