OrganOx

ABOUT ORGANOX: OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company's first product, the OrganOx metra normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally. Position Summary The Director, Product Quality oversees product quality efforts from our suppliers to the distribution and servicing of our products, while reflecting our core values of innovation, evidence, integrity, teamwork, respect, and a commitment to transplantation. The Director of Product Quality leads the strategy development, execution, and continuous improvement of product quality across the full lifecycle of Class III medical devices, from design through commercialization and post-market support. This role is accountable for ensuring compliance with global regulatory standards, driving product risk mitigation, and leading a team of engineers and quality professionals focused on design control, risk management, manufacturing quality, and field performance. As a key member of the quality leadership team, the Director works closely with R&D, Operations, Regulatory Affairs, and Clinical teams to deliver safe, effective, and compliant products to market. 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 Research and Development, Product Engineering, Supply Chain, Operations Servicing, and Distribution departments to create a cooperative environment that encourages teamwork and values each member's contributions. The Director will be responsible for the following Quality Teams: Design Assurance, Product Quality, Service Quality, Distribution Quality. Major Responsibilities Leadership & Strategy Build and lead a high-performing Product Quality Engineering team supporting new product development, sustaining engineering, and post-market oversight and improvement. Define and execute the strategic vision for product quality across Class III devices, aligned with business objectives and regulatory expectations. Partner with executive leadership on risk-benefit decisions, compliance priorities, and design transfer strategies. Design Control & Risk Management Oversee compliance with design control processes, including design input/output reviews, verification and validation (V&V), and design history file (DHF) completeness. Lead and review risk management activities (per ISO 14971), including hazard analysis, FMEA, and post-market risk assessment updates. Provide quality oversight for changes to design, processes, materials, and suppliers to ensure continued compliance. Product & Supplier Quality Collaborate with manufacturing and supplier quality teams to ensure seamless design transfer and robust product realization. Support process validation strategies (IQ/OQ/PQ) and monitor process capability and stability across the supply chain. Escalate and manage complex nonconformance investigations and product disposition decisions. Post-Market Quality & Product Improvement Oversee complaint trending, product performance analysis, and field issue investigation for commercialized Class III products. Partner with service, product engineering, and clinical lead the Service Quality Team in its role of customer advocate, trend identifier, and improvement programs. Regulatory & Compliance Ensure compliance with applicable regulations including FDA 21 CFR 820, ISO 13485, ISO 14971, EU MDR, and MDSAP. Support regulatory submissions (e.g., PMA, IDE, technical files) and interactions with FDA and other global health authorities. Serve as a subject matter expert during audits, inspections, and due diligence assessments. Detailed Responsibilities Provide overall Quality Engineering leadership including: Provide best-in-class expert level guidance and direction of the Quality Engineering Body of Knowledge, regulatory standards, and quality management Create an inclusive learning environment within the Product Quality Team that is aligned to OrganOx Values, Mission and aligned to business objectives. Proactively identifies opportunities to enhance 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. Communicate diligently with evidence-based communication to Executive Management team, peers, and team. Assess resource needs to ensure that the appropriate level of quality support is provided when needed with the competencies needed while operating within budget. 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 instill structured management process in problem solving throughout the organization While the above key responsibilities are the main elements of the titled job the Director, Director, Product Quality may at times request other tasks deemed to be within their capabilities. Skills and Experience 10+ years of quality engineering/assurance experience in the medical device industry, with at least 5 years in leadership capacity. Proven experience with Class III medical devices, including PMA and/or IDE products. Deep knowledge of design controls, risk management, process validation, and quality improvement. Strong understanding of global regulatory requirements: FDA QSR, ISO 13485, ISO 14971, EU MDR, MDSAP. Ability to travel Internationally (up to 30%) to support contract manufacturers and suppliers, visit OrganOx sites, and visit customer 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. Demonstratable project management skills with a passion for advancing quality, process improvement by winning through your team. Six Sigma, Lean, and Quality Improvement Familiarity with electronic QMS Software like MasterControl, Trackwise, and SAP Qualifications Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, or related field. ASQ Certifications (CQE, CMQ/OE, CQA) preferred 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 age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex, sexual orientation race, or any other characteristics protected by law.