Operations Quality Director

at  OrganOx

ABOUT ORGANOX:

OrganOx has been transforming organ transplantation since 2008, leveraging ground-breaking normothermic machine perfusion technology in our flagship product, the OrganOx metra®. This technology helps preserve donor livers for up to 24 hours, in efforts to reduce organ discard rates and facilitate more successful transplants. We are an innovative, fast-paced global medical device company committed to improving transplantation outcomes. As part of our ongoing expansion globally, we seek a motivated Director, Operations Quality, to join our team.

POSITION SUMMARY

The Director, Operations Quality oversees quality efforts from our suppliers to the distribution of our products, 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 that product performance and quality meet established standards and agency regulations. Guided by our vision, we are dedicated to transforming transplantation and achieving our mission of saving lives by making every donor organ count.
In this position, the Director will have broad decision-making responsibilities and be accountable for the accuracy and timeliness of those decisions, as well as for deploying organizational resources to resolve issues. Reporting directly to the Vice President of Quality, the Director will collaborate closely with the Supply Chain, Manufacturing, and Distribution departments to create a cooperative environment that encourages teamwork and values each member’s contributions.

SKILLS AND EXPERIENCE

• 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.

Provide overall Quality Engineering leadership including:

• 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 that is aligned to OrganOx Values, Mission and aligned to business objectives.
• Lead and define Quality organizational business deliverables in support of the Product Development Process
• Proactively identifies 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 that is 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.

While the above key responsibilities are the main elements of the titled job the Director, Operations Quality may at times request other tasks deemed to be within their capabilities.