Operations Quality Leader

1 day ago


Oxford, Oxfordshire, United Kingdom OrganOx Full time
About OrganOx

OrganOx is a pioneering medical device company that has revolutionized the field of organ transplantation. With a strong focus on innovation, evidence, and integrity, we aim to improve transplantation outcomes worldwide.

Estimated Salary: $120,000 - $180,000 per year

As a global commercial stage organ technology company spun out of the University of Oxford in 2008, we have been at the forefront of developing life-changing solutions. Our products, such as the OrganOx metra normothermic machine perfusion (NMP) system for liver transplantation, have supported over 4,000 liver transplant operations globally.

About the Role

We are seeking an experienced Operations Quality Director to oversee quality efforts from our suppliers to the distribution of our products. This role requires strategic leadership, technical expertise, and exceptional communication skills to drive compliance excellence, value improvement, risk reduction, and cost containment.

Main Responsibilities:
  • Quality Engineering Leadership: Provide overall vision and direction to Site Quality Managers and their teams.
  • Supplier Assurance: Direct the activities of the Supplier Assurance Team.
  • Distribution Quality: Oversee the activities of the Distribution Quality Team.
  • Quality Metrics and Process Improvement: Develop and continually improve quality metrics and process improvements.
  • Regulatory Compliance: Ensure compliance with domestic and international regulatory requirements and regulating bodies.
Requirements:

To be successful in this role, you will need:

  • 10+ years of quality experience with at least 3 years of management experience.
  • A Class III or II medical device background.
  • Demonstrated extensive experience with domestic and international regulatory requirements and regulating bodies.
  • The ability to travel internationally to support supplier and manufacturing sites.
  • Influential and inclusive leadership skills with a proven track record of creating momentum and delivering exceptional results.
About You

You should be a motivated and forward-thinking professional with a passion for advancing quality and process improvement. A 4-year degree in bioscience, engineering, or a related field is required.



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