Director of Quality Operations

4 weeks ago


Oxford, Oxfordshire, United Kingdom OrganOx Full time
Director, Operations Quality

OrganOx is a pioneering medical device company dedicated to revolutionizing organ transplantation. We are seeking a highly skilled Director, Operations Quality, to lead our quality efforts and ensure the highest standards of product performance and quality.

Key Responsibilities:
  • Develop and implement quality assurance and engineering programs, policies, processes, procedures, and controls to meet established standards and agency regulations.
  • Provide leadership and guidance to Site Quality Managers and their teams, ensuring a cooperative environment that encourages teamwork and values each member's contributions.
  • Oversee the activities of the Distribution Quality Team and create an inclusive learning environment within the Quality Team aligned to OrganOx Values and Mission.
  • Lead and define Quality organizational business deliverables in support of the Product Development Process, identifying opportunities to assure compliance to all applicable internal, domestic, and international quality regulations.
  • Identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
  • Communicate diligently and evidence-based communication to Executive Management team, peers, and team.
  • Assess resources needs to assure that the appropriate level of quality support is provided when needed with the competencies needed.
  • Oversee the non-conformance and real-time data management portions of the Quality System, developing and continually improving a Supplier Management Program.
  • Champion post-production risk management activities to include complaint investigation, risk analysis, and action deployment to resolve any issues.

The ideal candidate will have 10+ years in quality, with at least 3 years of management experience in demonstrated compliance excellence, value improvement, risk reduction, and cost containment. A Class III or II medical device background and extensive experience with domestic and international regulatory requirements and regulating bodies are required. Ability to travel internationally to support supplier and manufacturing sites is also necessary. A 4-year degree in bioscience, engineering, or equivalent is preferred.

OrganOx is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and respectful work environment that values each member's contributions.



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