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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 role involves auditing key suppliers to ensure compliance with ISO 9001:2016 and cGMP standards.
The ideal candidate will have experience working in the Medical Device industry, with a strong understanding of GDP/GMP requirements. They will be responsible for administering the Supplier Corrective Action Reports (SCAR) process, ensuring all suppliers are approved and evaluated in accordance with ISO 13485 and 21 CFR Part 820.
The successful candidate will have excellent communication and problem-solving skills, with the ability to travel and work independently. They will be responsible for supporting suppliers throughout the SCAR process, facilitating root cause analysis and assisting with the creation of KPIs to effectively manage and monitor supplier quality.
Key responsibilities will include:
- Auditing of 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, ensuring all are raised and investigated in a timely manner.
- Supporting suppliers throughout the SCAR process, 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 work independently.
