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Supplier Quality Assurance Specialist
2 months ago
X4 Life Sciences is seeking a highly skilled Supplier Quality Assurance Specialist to join their team in Oxford. This is a fantastic opportunity for a quality professional to work with a growing Medical Device company and contribute to the development of their quality management system.
The ideal candidate will have experience in auditing suppliers to ISO 9001:2016 and cGMP, as well as ensuring all suppliers are approved and evaluated in accordance with ISO 13485 and 21 CFR Part 820. They will also have expertise in administering the Supplier Corrective Action Reports (SCAR) process and supporting suppliers throughout the SCAR process.
The successful candidate will be responsible for:
- Auditing key suppliers to ISO 9001:2016 and cGMP in accordance with the supplier audit schedule.
- Ensuring all suppliers are approved and routinely evaluated in accordance with ISO 13485 and 21 CFR Part 820.
- Administering the SCAR process and ensuring all reports are raised and investigated in a timely manner.
- Supporting suppliers throughout the SCAR process, including facilitating root cause analysis when required.
- Assisting with the creation of KPIs to effectively manage and monitor supplier quality.
- Supporting investigations of suppliers involved with any feedback, Post-Market Surveillance or customer complaints.
- Supporting the RMA process by liaising with suppliers and assisting with material transfer.
- Ensuring all Design changes and implemented improvements and related SOP and other related documents are communicated to the supplier when required.
Requirements:
- Experience of working in Quality within the Medical Device industry.
- Supplier Audit Experience - ISO 13485, 21 CFR Part 820 Lead Auditor qualified.
- Working knowledge of GDP/GMP requirements.
- Ability to travel and be out of the country for considerable periods of time.
X4 Life Sciences offers a competitive salary and benefits package to the successful candidate. If you are a motivated and experienced quality professional looking for a new challenge, please submit your CV for consideration.
