Supplier Quality Manager
2 weeks ago
X4 Life Sciences is seeking a highly skilled Quality Assurance Specialist to join their team in Oxford. The ideal candidate will have experience in auditing key suppliers to ISO 9001:2016 and cGMP, and will be responsible for ensuring all suppliers are approved and evaluated in accordance with ISO 13485:2016 and 21 CFR Part 820.
The Quality Assurance Specialist will be responsible for administering the Supplier Corrective Action Reports (SCAR) process, and will work closely with suppliers to facilitate root cause analysis and implement corrective actions. The role will also involve assisting with the creation of Key Performance Indicators (KPIs) to effectively manage and monitor supplier quality.
The successful candidate will have a strong understanding of quality management systems and will be able to communicate effectively with suppliers and internal stakeholders. They will also have experience with travel and be able to work independently with minimal supervision.
Key Responsibilities:
- Audit key suppliers to ISO 9001:2016 and cGMP
- Ensure all suppliers are approved and evaluated in accordance with ISO 13485:2016 and 21 CFR Part 820
- Administer the SCAR process and facilitate root cause analysis
- Assist with the creation of KPIs to manage and monitor supplier quality
- Support suppliers throughout the SCAR process
- Assist with new supplier approval process
- Support investigations of suppliers involved with feedback or customer complaints
- Support the Return Material Authorization (RMA) process
- Ensure all design changes and implemented improvements are communicated to suppliers
Requirements:
- Experience in quality assurance 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
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