Description:
Currently assisting an extremely exciting MedTech client situated in the Oxford area. The are seeking to recruit a Senior Quality Engineer to join an expanding team. You will be reporting directly to the Head of Quality as well as liaising regularly with other departments.
This position will be a mix of hybrid and on site 3 days a week.
KEY RESPONSIBILITIES
- Work closely with the product development team providing quality input to design & development.
- Provide guidance to ensure products and associated design and development processes are compliant with required standards for design and development of medical devices and risk management as per ISO 13485, ISO 14971, 21 CFR 820 and other applicable regulatory requirements.
- Lead audits both internally & externally
- Accountable for the QMS metrics and lead the efforts towards addressing Open NC's, CAPA's
SKILLS & EXPERIENCE
- Degree within a relevant subject such as biomedical sciences, medical diagnostics, clinical or science.
- You will be able to work well as part of a multidisciplinary team as well as independently as well as have strong attention to detail.
- Working knowledge of the application of FDA Quality System Regulation, 21 CFR 820, ISO 13485 Quality system standards for medical device and ISO 14971 Risk Management Systems to product development and manufacture Hands on quality engineering experience in new product design and development and manufacturing.
- Qualified auditor to BSI standard (or equivalent).
- Strongly beneficial to have working knowledge of SaMD or IEC 62304