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 enhancing transplant success. As a fast-paced, innovative company, we are committed to improving transplantation outcomes and seeking a motivated Supplier Quality Engineer to join our team.
Job Summary:
The Supplier Quality Engineer will be responsible for managing supplier activities, conducting quality audits, and evaluating new suppliers to ensure compliance with ISO 13485, CFR 820, and other regulatory requirements. This role will involve significant travel and collaboration with the Quality Assurance, Operations, and Goods Inwards teams.
Key Responsibilities:
- Conducting audits of key suppliers to ISO 9001:2016 and cGMP for OrganOx, as per the supplier audit schedule.
- Ensuring all suppliers for OrganOx are approved and routinely evaluated in accordance with ISO 13485:2016 and 21CFR Part 820.
- Administering the Supplier Corrective Action Reports (SCAR) process, ensuring timely investigation and resolution of issues.
- 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 the new supplier approval process, including evaluation and re-evaluation.
- Assisting with the creation and updating of SOPs and WIs related to supplier quality management.
- Supporting the investigation of suppliers involved in feedback, Post-Market Surveillance, or customer complaints.
- Supporting the RMA process by liaising with suppliers and assisting with material transfer.
- Maintaining good working relationships with suppliers to ensure resolution of any CA arising from supplier audits.
- Ensuring all design changes and implemented improvements are communicated to suppliers when required.
- Acting as a Subject Matter Expert for the area of expertise, maintaining knowledge of relevant procedures and specifications.
Requirements:
- Experience working in Quality within the Medical Device industry.
- Supplier Audit Experience - ISO 13485.
- 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.
- Knowledge of Master Control (desirable).
Qualifications:
- A degree in bioscience, engineering, or equivalent, or other related field.
Benefits:
At OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide opportunities for ongoing professional development.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.
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