Quality Assurance Specialist for Suppliers
1 month ago
Are you eager to advance your career in a pioneering and rapidly expanding medical device organization? OrganOx is dedicated to creating products that enhance lives by maximizing the potential of every donated organ. Our vibrant team is committed to excellence in the organ transplantation sector, and you could play a vital role in our journey.
We are seeking a Supplier Quality Engineer who will oversee daily operations within the Quality Assurance team, ensuring that audits and supplier visits are executed effectively.
The ideal candidate will be responsible for managing supplier-related activities through quality audits, assessments, and the evaluation and onboarding of new suppliers, establishing clear quality expectations.
This position entails ensuring compliance across all supply chain operations at OrganOx (including supplier management, projects, and distribution) to adhere to standards such as ISO 13485, CFR 820, CMD/CAS, and Directive 43/92 EEC, as well as Medical Device regulations.
The role will report directly to the Supplier Quality Team Leader and will closely collaborate with Quality Assurance, Operations, and Goods Inwards.
We implement a hybrid work policy, allowing for 3 days of remote work each week.
Key Responsibilities:
- Conduct audits of key suppliers to ISO 9001:2016 & cGMP for OrganOx as per the supplier audit schedule, which may require significant travel.
- Ensure all suppliers are approved and routinely assessed in compliance with ISO 13485:2016 & 21CFR Part 820 (and other applicable regulations).
- Manage the Supplier Corrective Action Reports (SCAR) process, ensuring timely initiation and investigation of all reports.
- Assist suppliers throughout the SCAR process, facilitating root cause analysis as necessary.
- Contribute to the development of KPIs to effectively monitor and manage supplier quality.
- Support the new supplier approval process, including evaluation and re-evaluation of suppliers.
- Help create and update Standard Operating Procedures (SOPs) and Work Instructions (WIs) related to supplier quality management.
- Assist in investigating suppliers involved in feedback, Post-Market Surveillance, or customer complaints.
- Support the Return Merchandise Authorization (RMA) process by coordinating with suppliers and facilitating material transfers.
- Maintain positive relationships with suppliers to ensure timely resolution of any corrective actions resulting from audits.
- Ensure that all design changes and implemented improvements, along with related SOPs and documents, are communicated to suppliers as necessary.
- Act as a Subject Matter Expert in your area of expertise by staying informed about relevant procedures and specifications related to your role, including participation in external audits (e.g., BSI, FDA).
- Support and complete any additional tasks assigned by the QC/QA Manager.
Required Skills:
- Experience in Quality Assurance within the Medical Device sector.
- A degree in bioscience, engineering, or a related field.
- Supplier Audit Experience - ISO 13485, 21 CFR part 820 Lead Audit Qualified.
- Familiarity with GDP/GMP requirements.
- Exceptional organizational skills.
- Strong attention to detail.
- Excellent written and verbal communication abilities.
- Willingness to travel and be away from home for extended periods.
- Knowledge of Master Control is desirable.
At OrganOx, we value diversity and seek to recruit and retain exceptional individuals from a wide range of backgrounds who share our commitment to innovation, integrity, teamwork, respect, and passion. If you resonate with these values and are looking for an opportunity to grow and thrive, we encourage you to consider this role.
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