Supplier Quality Assurance Specialist
4 weeks ago
About OrganOx:
OrganOx is a pioneering medical device company that has been revolutionizing organ transplantation since 2008. Our flagship product, the OrganOx metra, utilizes groundbreaking normothermic machine perfusion technology to preserve donor livers for up to 24 hours, reducing organ discard rates and improving transplantation outcomes. As a fast-paced and innovative company, we are seeking a motivated Supplier Quality Assurance Specialist to join our team.
Job Summary:
The Supplier Quality Assurance Specialist will be responsible for ensuring the quality of our suppliers by conducting audits and assessments, evaluating new suppliers, and establishing quality expectations. This role will also be responsible for ensuring compliance with ISO 13485, CFR 820, and other relevant regulations across our supply chain activities.
Key Responsibilities:
- Conduct audits of key suppliers to ISO 9001:2016 and cGMP standards.
- Ensure all suppliers are approved and routinely evaluated in accordance with ISO 13485:2016 and 21CFR Part 820.
- Administer the Supplier Corrective Action Reports (SCAR) process and ensure all issues are investigated and resolved in a timely manner.
- Support suppliers throughout the SCAR process and facilitate root cause analysis when required.
- Assist with the creation of Key Performance Indicators (KPIs) to effectively manage and monitor supplier quality.
- Support the new supplier approval process, including evaluation and re-evaluation.
- Assist with the creation and updating of Standard Operating Procedures (SOPs) and Work Instructions (WIs) related to supplier quality management.
- Support the investigation of suppliers involved in customer complaints, Post-Market Surveillance, or feedback.
- Support the Return Material Authorization (RMA) process by liaising with suppliers and assisting with material transfer.
- Maintain good working relationships with suppliers to ensure resolution of any issues arising from supplier audits.
- Ensure all design changes and implemented improvements are communicated to suppliers when required.
- Act as a Subject Matter Expert for supplier quality management and participate in external audits.
Requirements:
- Experience working in Quality within the Medical Device industry.
- Supplier audit experience to ISO 13485 standards.
- Working knowledge of GDP/GMP requirements.
- Excellent organizational skills.
- Good attention to detail.
- Strong written and oral communication skills.
- Ability to travel and be out of the country for considerable periods of time.
- Knowledge of Master Control (desirable).
Qualifications:
- A degree in bioscience, engineering, or equivalent or other related field.
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