Medical Device Quality Assurance Specialist
1 day ago
We are a global medical device company committed to improving transplantation outcomes. Our flagship product, the OrganOx metra, uses normothermic machine perfusion technology to preserve donor livers for up to 24 hours, reducing organ discard rates and facilitating successful transplants.
Job Description:Key Responsibilities- Audit suppliers to ensure compliance with ISO 9001:2016 and cGMP standards.
- Evaluate and approve suppliers in accordance with ISO 13485:2016 and 21CFR Part 820.
- Administer the Supplier Corrective Action Reports (SCAR) process to ensure timely investigations and resolution of issues.
- Support suppliers throughout the SCAR process, facilitating root cause analysis when required.
- Assist with the creation of KPIs to effectively manage and monitor supplier quality.
- Support new supplier approval processes, including evaluation and re-evaluation.
- Assist with the creation and updating of SOPs and WIs related to supplier quality management.
- Investigate suppliers involved in feedback, Post-Market Surveillance, or customer complaints.
- Liaise with suppliers to resolve CA issues and close them in accordance with the CA plan.
- Ensure design changes and implemented improvements are communicated to suppliers.
- Maintain knowledge of relevant procedures and specifications to act as a Subject Matter Expert.
- Experience working in Quality within the Medical Device industry.
- Supplier audit experience - ISO 13485.
- Working knowledge of GDP/GMP requirements.
- Excellent organisation skills.
- Good attention to detail.
- Strong written and oral communication skills.
- Ability to travel internationally for extended periods.
- A degree in bioscience, engineering, or equivalent field.
£60,000 - £80,000 per annum based on location and experience.
BenefitsWe offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide opportunities for ongoing professional development.
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