Operations Quality Director

4 weeks ago

Oxford, Oxfordshire, United Kingdom OrganOx Full time

About OrganOx:

OrganOx is a pioneering medical device company dedicated to transforming organ transplantation. 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 a fast-paced, innovative organization committed to improving transplantation outcomes.

Job Summary:

The Director of Quality Operations will oversee quality efforts from suppliers to product distribution, reflecting our core values of innovation, evidence, integrity, teamwork, respect, and a commitment to transplantation. This role is crucial in developing, establishing, and maintaining quality assurance and engineering programs, policies, processes, procedures, and controls to ensure product performance and quality meet established standards and agency regulations.

Key Responsibilities:

  • Provide overall Quality Engineering leadership, setting the vision and direction of Site Quality Managers and their teams.
  • Direct the activities of the Supplier Assurance Team, overseeing the activities of the Distribution Quality Team.
  • Offer best-in-class expert level guidance and direction of the Quality Engineering Body of Knowledge.
  • Create an inclusive learning environment within the Quality Team, aligned to OrganOx Values, Mission, and business objectives.
  • Lead and define Quality organizational business deliverables in support of the Product Development Process.
  • Proactively identify opportunities to assure compliance to all applicable internal, domestic, and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
  • Identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
  • Provide leadership aligned with OrganOx Values and Mission Statement with peers and teams to drive proactive quality improvements.
  • Identify Quality Initiatives and lead cross-functional teams to complete them.
  • 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.
  • Develop and continually improve a Supplier Management Program.
  • Champion post-production risk management activities to include complaint investigation, risk analysis, and action deployment to resolve any issues.
  • Be an effective member of the cross-functional leadership organization to foster continuous quality compliance, cost, and predictive measures improvements.
  • Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
  • Be a champion of Quality, and become the subject matter expert in Six Sigma, Lean, and instil structured management process in problem solving throughout the organization.

Requirements:

  • 4-year degree, Master's Preferred or equivalent experience.
  • 10+ years in quality desired with at least 3 years management of demonstrated compliance excellence, value improvement, risk reduction, and cost containment.
  • Class III or II medical device background.
  • Demonstrated extensive experience with domestic and international regulatory requirements and regulating bodies required.
  • 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 within the framework of our values of teamwork and respect.
  • Demonstrable project management skills with a passion for advancing quality, process improvement by winning through your team.
  • Six Sigma Black Belt desired.

Qualifications:

A 4-year degree in bioscience, engineering, or equivalent or other related field.

Benefits:

At OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide opportunities for ongoing professional development.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.

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