Supplier Quality Engineer

at  OrganOx

ABOUT ORGANOX:

OrganOx has been transforming organ transplantation since 2008, leveraging ground-breaking normothermic machine perfusion technology in our flagship product, the OrganOx metra®. This technology helps preserve donor livers for up to 24 hours, in efforts to reduce organ discard rates and facilitate more successful transplants. We are an innovative, fast-paced global medical device company committed to improving transplantation outcomes. As part of our ongoing expansion, we seek a motivated Supplier Quality Engineer to join our team.

POSITION SUMMARY

The position of Supplier Quality Engineer is responsible for undertaking the day to day activities within the Quality Assurance team ensuring audits and visits are conducted within OrganOx. The purpose of the role is to manage supplier activities by means of quality audits assessments and the evaluation and introduction of new suppliers by means of quality assessment and establishing quality expectations. The role is responsible for the compliance activities across all OrganOx supply chain activities (supplier management, projects, distribution), to meet the requirements of ISO 13485, CFR 820, CMD/CAS, Directive 43/92 EEC, Medical Device requirements. This role will report directly to the Supplier Quality Team Leader and will be strongly aligned with Quality Assurance, Operations and Goods Inwards. Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive, and the person will be expected to complete tasks reasonably requested by the QA/QC Manager. This is a flexible, on-site role in our Oxford office to ensure effective control of the manufacturing and service documentation, and collaboration with both the Operations and Quality teams. International travel will also be required as a significant part of this role.

SKILLS AND EXPERIENCE

• Experience of 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 and be out of the country for considerable periods of time
• Knowledge of Master Control (Desirable)

QUALIFICATIONS

The Supplier Quality Engineer will have:

• A degree in bioscience, engineering or equivalent or other related field

Under direction from the QA/QC Manager or Supplier Quality Team Lead will be responsible for:

• Auditing of key suppliers to ISO 9001:2016 & cGMP for OrganOx in accordance with the supplier audit schedule. This role will involve significant travel at times.
• Ensure all suppliers for OrganOx are approved and routinely evaluated in accordance with ISO 13485:2016 & 21CFR Part 820 (other territories may apply)
• Administer the Supplier Corrective Action Reports (SCAR) process, ensure all are raised and investigated within a timely manner.
• 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.
• Assist with new supplier approval process, including new supplier evaluation/re-evaluation.
• Assist with the creation and updating of SOPs and WIs related to supplier quality management.
• Support investigation of suppliers involved with any feedback, Post-Market Surveillance or customer complaints.
• Support the RMA process by liaising with suppliers and assisting with material transfer.
• Maintain good working relationships with suppliers to ensure resolution of any CA arising from supplier audits are closed in accordance with the CA plan.
• Ensure all Design changes and implemented improvements and related SOP and other related documents are communicated to the supplier when required.
• Act as Subject Matter Expert for area of expertise by maintaining knowledge of the relevant procedures and specifications related to current job specification. To include participating in and supporting external audits e.g. BSI, FDA etc.
• Support and complete any other work-related tasks set by the QC/QA Manager.

While the above key responsibilities are the main elements of the titled job the QC/QA Manager may at times request other tasks deemed to be within their capabilities.