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 companys 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 Senior Product Quality Engineer develops andoversees product and device inspection and acceptance activities for the OrganOx Metra, a Class III medical device. These activities include but are not limited to development of first article inspection processes, oversight of incoming inspection, responsible for nonconforming material and material review board, and product acceptance. This position works closely with contracted manufacturers, suppliers, and quality inspectors to ensure day-to-day execution of these critical business processes and lead improvements of these processes.
This position involves supervisory responsibilities of Quality Inspectors and Technicians, as well as executing continuous improvement initiatives to improve product quality.
This is an onsite position in Oxford with flexibility.
Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive.
Major Responsibilities
Under direction from the Senior Manager, Product Quality Engineering, the Senior Product Quality Engineer may be responsible for:
Leadership and Team Development
Day to day management of quality inspectors and technicians
Define team goals in collaboration with the Sr. Manager, Product Quality Engineering
Manage performance reviews and development plans for quality inspectors and technicians
Day to Day management and monitoring of KPIs related to product quality (Ex- Investigation Aging, NC aging and resolution)
Promote a culture of accountability, collaboration and continuous improvement.
Technical Quality Engineering Oversight
Conducting hands on oversite of the device acceptance process, ensuring device acceptance targets are met.
Conducting hands-on oversight of the incoming inspection process, ensuring inspection targets are met.
Development of first article inspection processes
Conduct root cause investigations regarding non-conforming product
Lead and support continuous process improvements related to device acceptance and incoming inspection
Leading Material Review Board and dispositioning inspected product
Execution of non-conformances
Trending and analysis of non-conformance data to drive decisions
Support updates to specification templates and inspection criteria
Support development of inspection fixtures and tooling
Ensure calibration records are up to date
Lead and support quality process improvements, identify systemic issues and drive continuous improvement initiatives
Regulatory Compliance & QMS
Ensure adherence to regulatory standards: FDA 21 CFR 820, ISO 13485, EU MDR, MDSAP, etc
Support regulatory submissions, internal audits, and external inspections (e.g., FDA, Notified Body).
Maintain and improve quality processes and documentation within the QMS.
Cross-Functional Collaboration
Participate in Design Reviews and Change Control Boards.
Collaborate with suppliers and contract manufacturers on quality standards, audits, and issue resolution.
Communicate diligently with evidence-based communication to management and peers
Adhere to the letter and spirit of OrganOxs Code of Conduct and all other company policies
Requirements
Skills & Experience
Significant related quality engineering work experience within the medical device field or other highly regulated industry required
Knowledge of regulatory and quality standards: FDA QSR, ISO 13485, ISO 14971, EU MDR.
Demonstrable technical quality engineering skills including root cause analysis, test method development, fixture development, and project management
Experience working with nonconformances, first article inspections, CAPAs and SCARs
Proven track record of problem solving and improving quality processes
Experience using statistics and data analysis to solve quality problems
Ability to travel internationally up to 30% to support contract manufacturers and suppliers, visit OrganOx sites, and visit customer sites
Qualifications
Bachelors degree in Engineering, Life Sciences, or a related technical field required
ASQ Certifications (CQE, CMQ/OE, CQA) preferred
Six Sigma Green Belt or Black Belt Certification preferred
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 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.
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