Medical Device Quality Assurance Specialist

1 day ago


Oxford, Oxfordshire, United Kingdom OrganOx Full time
About OrganOx

We are a global medical device company committed to improving transplantation outcomes. Our flagship product, the OrganOx metra, uses normothermic machine perfusion technology to preserve donor livers for up to 24 hours, reducing organ discard rates and facilitating successful transplants.

Job Description:Key Responsibilities
  • Audit suppliers to ensure compliance with ISO 9001:2016 and cGMP standards.
  • Evaluate and approve suppliers in accordance with ISO 13485:2016 and 21CFR Part 820.
  • Administer the Supplier Corrective Action Reports (SCAR) process to ensure timely investigations and resolution of issues.
  • 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.
  • Support new supplier approval processes, including evaluation and re-evaluation.
  • Assist with the creation and updating of SOPs and WIs related to supplier quality management.
  • Investigate suppliers involved in feedback, Post-Market Surveillance, or customer complaints.
  • Liaise with suppliers to resolve CA issues and close them in accordance with the CA plan.
  • Ensure design changes and implemented improvements are communicated to suppliers.
  • Maintain knowledge of relevant procedures and specifications to act as a Subject Matter Expert.
Skills and Experience
  • Experience 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 internationally for extended periods.
Qualifications
  • A degree in bioscience, engineering, or equivalent field.
Estimated Salary Range

£60,000 - £80,000 per annum based on location and experience.

Benefits

We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide opportunities for ongoing professional development.



  • Oxford, Oxfordshire, United Kingdom newscientist - Jobboard Full time

    Quality Assurance SpecialistWe are seeking a highly motivated Quality Assurance Specialist to join our team at Oxford Nanopore Technologies. As a key member of our Quality Assurance team, you will be responsible for ensuring that our suppliers meet the highest standards of quality and compliance.Your primary focus will be on working closely with our...


  • Oxford, Oxfordshire, United Kingdom Lenntech Search Full time

    Quality Assurance RoleLenntech Search is seeking a Quality Assurance Specialist to join the QA & compliance team of a fast-growing medical device client.The successful candidate will play a key role in ensuring the company's ISO 13485 quality management system is established, implemented, maintained, monitored, and continuously improved.Main...


  • Oxford, Oxfordshire, United Kingdom Skills Alliance Full time

    Job Title: Quality Assurance Specialist, QMS ExpertJob Type: PermanentLocation: Global (hybrid)Skills Alliance is seeking a highly skilled Quality Assurance Specialist to oversee the evaluation of our QMS and provide leadership in the development and delivery of QMS training materials to all employees. This is an opportunity to work in a fast-paced global...


  • Oxford, Oxfordshire, United Kingdom Oxford University Hospitals Full time

    Job OverviewWe are seeking a highly skilled Medical Device Specialist to join our Clinical Engineering Group at the Oxford University Hospitals NHS Foundation Trust.This role will involve the whole life cycle of medical devices, from acceptance and maintenance to repair and disposal. The successful candidate will have strong technical skills, including...


  • Oxford, Oxfordshire, United Kingdom Skills Alliance Full time

    Job Title: Senior Quality Assurance Specialist Salary: £60,000 - £80,000 per annum About the RoleWe are seeking a highly motivated and experienced Supplier Quality Engineer to join our team at Skills Alliance.The successful candidate will assist in sustaining and enhancing our Global Supplier Quality program, conduct internal investigations through...


  • Oxford, Oxfordshire, United Kingdom Oxford University Hospitals Full time

    Job OverviewWe are seeking a skilled Medical Device Specialist to join our Clinical Engineering Group at the Oxford University Hospitals NHS Foundation Trust.This role will involve working with a wide range of medical equipment, from acceptance and maintenance to repair and disposal. The successful candidate will have strong technical skills, excellent...


  • Oxford, Oxfordshire, United Kingdom OrganOx Full time

    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...


  • Oxford, Oxfordshire, United Kingdom OrganOx Full time

    At OrganOx, we are committed to improving transplantation outcomes by leveraging innovative technologies in the medical device industry. As a key member of our Quality Assurance team, you will play a critical role in ensuring the highest standards of quality and compliance across our supply chain. Your expertise in quality management and auditing will be...


  • Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full time

    Oxford Nanopore Technologies is a leading biotechnology company that offers real-time analysis and sequencing solutions. We are seeking a highly motivated individual to join our Quality Assurance team as a Supplier Quality Engineer.The successful candidate will be responsible for monitoring supplier compliance to specifications and contractual arrangements,...


  • Oxford, Oxfordshire, United Kingdom The Recruitment Group Full time

    Our client, a global leader in medical device design and manufacture, is seeking a Medical Device Inspector to join their team in a laboratory setting.Key responsibilities include:Visual inspection of medical devices and partsFilling syringes with a water/glycerine mixTesting of development devicesRequirements for the role include:Ability to work...


  • Oxford, Oxfordshire, United Kingdom OrganOx Full time

    About OrganOxOrganOx is a pioneering medical device company that has been transforming 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 facilitating more successful transplants.We are...


  • Oxford, Oxfordshire, United Kingdom OrganOx Full time

    About OrganOx:OrganOx is a leading medical device company dedicated to transforming organ transplantation through innovative technologies. Our flagship product, the OrganOx metra, utilizes normothermic machine perfusion to preserve donor livers for up to 24 hours, reducing discard rates and improving transplant success.We are seeking a highly motivated...


  • Oxford, Oxfordshire, United Kingdom OrganOx Full time

    About OrganOxOrganOx is a leading global medical device company dedicated to improving transplantation outcomes. We leverage innovative technology to transform organ transplantation, and our flagship product, the OrganOx metra, has revolutionized the field.Job SummaryWe are seeking a highly motivated Supplier Quality Engineer to join our team. The successful...


  • Oxford, Oxfordshire, United Kingdom OrganOx Full time

    Transforming Transplantation OutcomesWe are an innovative medical device company committed to improving transplantation outcomes. As part of our ongoing expansion, we seek a motivated Device Verification Specialist to join our team.


  • Oxford, Oxfordshire, United Kingdom Skills Alliance Full time

    Job Title: Director of Quality AssuranceAbout the Role:We are seeking a highly experienced Director of Quality Assurance to join our team at Skills Alliance. In this role, you will be responsible for developing, establishing, and maintaining quality assurance programs, policies, processes, procedures, training materials, and controls enhancing the...


  • Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full time

    Oxford Nanopore Technologies is seeking a highly motivated and experienced Supplier Quality Engineer to join their Quality Assurance team. The successful candidate will play a key role in ensuring that suppliers meet the company's quality standards and regulatory requirements.Key Responsibilities:Supplier Quality Management: Work closely with Engineering,...


  • Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full time

    Oxford Nanopore Technologies seeks a skilled professional to join their Quality Assurance team as a Supplier Quality Engineer.As a key member of the team, you will be responsible for monitoring supplier compliance to specifications and contractual arrangements. You will work closely with various departments, including Engineering, Procurement, Supply Chain,...

  • Production Supervisor

    4 weeks ago


    Oxford, Oxfordshire, United Kingdom Amber Therapuetics Full time

    Job DescriptionWe are seeking a highly skilled and experienced Production Supervisor to join our team at Amber Therapeutics. As a Production Supervisor, you will be responsible for supervising a small production team within a medical device R&D environment.Key Responsibilities:Production scheduling to ensure that the required units are manufactured on time...


  • Oxford, Oxfordshire, United Kingdom OrganOx Full time

    Design Assurance Manager Job SummaryOrganOx is a global medical device company committed to improving transplantation outcomes through innovative technology. We seek a skilled Design Assurance Manager to oversee quality efforts in support of our product development and design change activities.Key Responsibilities:Lead quality assurance and engineering...


  • Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full time

    About the Role:Oxford Nanopore Technologies is a leading company in the field of nanopore science, with a presence in multiple locations across the globe. We are seeking a highly motivated and self-starting individual to join our Quality Assurance team as a Supplier Quality Engineer.Key Responsibilities:Build and maintain processes to improve supplier...