Supplier Quality Assurance Specialist

2 weeks ago


Oxford, Oxfordshire, United Kingdom OrganOx Full time

About OrganOx

OrganOx is a leading medical device company that has been transforming organ transplantation since 2008. We leverage groundbreaking normothermic machine perfusion technology in our flagship product, the OrganOx metra, to preserve donor livers for up to 24 hours and reduce organ discard rates. As a fast-paced and innovative company, we are committed to improving transplantation outcomes. We are seeking a qualified Supplier Quality Engineer to join our team.

Job Summary

The Supplier Quality Engineer will be responsible for ensuring the quality of our suppliers by conducting audits and assessments. This role will involve evaluating and introducing new suppliers, managing supplier activities, and ensuring compliance with regulatory requirements. The successful candidate will work closely with the Quality Assurance team to maintain good working relationships with suppliers and resolve any issues that may arise.

Key Responsibilities

  • Audit and assess key suppliers to ensure compliance with ISO 9001:2016 and cGMP
  • Manage supplier activities and ensure all suppliers are approved and evaluated regularly
  • Administer the Supplier Corrective Action Reports (SCAR) process and support suppliers throughout the process
  • Assist with the creation of KPIs to effectively manage and monitor supplier quality
  • Support the new supplier approval process and assist with the creation and updating of SOPs and WIs related to supplier quality management
  • Support the investigation of suppliers involved in 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 and ensure resolution of any issues that may arise

Requirements

  • 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

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


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