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Full-time
bachelor degree, professional certificate
Healthcare, Retirement Plans, Professional Development
Posted 20d ago
~40 hrs/week
Responsibilities
The Product Quality Engineer monitors and improves the performance of the Metra Class III medical device through data analysis and trend monitoring. They collaborate with suppliers and cross-functional teams to resolve non-conformances and implement manufacturing improvements to mitigate field failures.
Requirements
Candidates must hold a Bachelor's degree in an Engineering discipline and possess hands-on experience in the medical device industry. Proficiency in root cause analysis, statistical tools like Minitab, and knowledge of FDA QSR and ISO 14971 are highly desired.
Full job description
ABOUT ORGANOX
OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP). It's flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfil its mission of “Contributing to Society through Healthcare” by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.
Position Summary
The Product Quality Engineering team at OrganOx is a technical quality engineering team responsible for monitoring, understanding, and improving product performance of the OrganOx Metra, a Class III medical device. The Product Quality Engineering team works closely with Product Sustaining Engineering and Contracted Suppliers to set in place quality control and management processes for externally built products and componentry, including sterilization and microbiology, supplier management, and contract manufacturing processes.
The Product Quality Engineer will have strong technical skills with an ability to analyze product quality issues and work cross-functionally to solve problems related to product quality.
The successful candidate is collaborative, has excellent communication and problem-solving skills, and is passionate about delivering world-class products that make healthcare more accessible, simpler, and safer.
This is a flexible, on-site role in Oxford, UK.
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 Product Quality Engineer and Senior Manager, Product Quality Engineering, the Product Quality Engineer may be responsible for the following:
Analyze and trend on product performance data to provide recommendations for product improvements
Investigation and disposition of nonconforming material through Non-Conforming Material (NCMR) and Supplier Corrective Action Reports (SCARs) processes in response to product performance trends.
Support root cause investigation and timely closure of SCARs
Work cross-functionally with other engineering teams and contracted suppliers to implement changes in manufacturing and inspection procedures to mitigate field failures.
Maintain good working relationships with suppliers to support root cause investigation and failure mitigation efforts
Supports updates to supplier quality agreements
Support hands-on analyses of returned products to identify root causes of failures
Support development of investigation criteria and test methods to properly diagnose and root cause field failures
Provide technical insight to sterilization and microbiological processes
Support CAPAs, Escalations, and engineering investigations in response to field quality issues.
Participate in the development and review of engineering change orders that impact product quality activities
Perform DHR, Service History record, and PFMEA reviews in support of complaint investigations
Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies.
Skills & Experience
Demonstrable related hands on engineering experience in the medical device industry, or equivalent.
Knowledge of electro-mechanical troubleshooting techniques
Familiarity with ISO14971 and associated Risk Management Processes is a plus
Knowledge of medical device sterilization and microbiology preferred
Excellent technical report writing skills
Strong Root Cause Analysis, Design Of Experiments, and test method development experience as related to complaint investigations
Experience investigating and resolving SCARS and CAPAs
A solid understanding of the FDA QSR Quality System Requirements, and the ability to apply the knowledge to comply with goals and objectives.
Strong experience with MS Office Products (Word, Excel, Visio, Project, PowerPoint, Outlook, etc.)
Strong experience with statistical analysis of data. Experience with Minitab preferred.
Experience with Six Sigma principles preferred.
Excellent oral and written communication skills with the ability to communicate with audiences of varying technical skills
A strong ability to prepare written technical plans and reports in support of engineering changes, product or process validations, and failure investigations.
Strong focus on meeting customer needs.
Proven ability to work cross functional and within global teams, fostering a culture of high collaboration.
Ability to be self-driven and solve complex problems independently. Committed to upholding OrganOx values in daily work and decision-making.
Experience in driving a global quality mindset across teams and geographies.
Demonstrated strong attention to detail and “do it right the first time” attitude
Qualifications
Bachelor’s degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, etc.) or the equivalent work experience
Ability to travel 10-20%
Six Sigma Green Belt or Black Belt Certification 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.
Related keywords
Medical DeviceClass III DeviceNormothermic Machine PerfusionNCMRSCARCAPAISO 14971FDA QSRMinitabSix Sigma Green BeltSix Sigma Black BeltPFMEADHRRoot Cause AnalysisDesign Of ExperimentsSterilization
Our mission is to save lives by making every organ count
Industry
Medical Equipment Manufacturing
Company size
51-200 employees
Founded
2008
Headquarters
Oxford, England
LinkedIn followers
43,368
Total funding
$207M
Transforming transplantation with the OrganOx metra®. A transportable, automated ex vivo liver perfusion device.
The core technology employed by the OrganOx metra® has been in development for over 15 years. During this time both of the founders (Professor Peter Friend and Professor Constantin Coussios) have driven the development of organ preservation and maintenance, formerly at the University of Cambridge and latterly at the University of Oxford.
OrganOx Limited was founded in April 2008 as a spin-out from the University of Oxford.
Conventional cold preservation involves storage of the liver at 4˚C, using a non-physiological perfusion solution that aims to minimise liver decay. By contrast, warm preservation seeks to re-create an environment that mimics the human body by continuously perfusing at physiological pressures and flows with oxygen-carrying red cells at 37˚C and providing nutrition. The liver is therefore functional during the preservation period, producing bile, metabolizing glucose and maintaining a physiological pH. This enables objective assessment of organ performance prior to transplant, extended preservation times, and the potential use of organs that are presently being discarded.
Offices: 3500 John Smith Drive, Oxford, England OX4 2WB, GB
How many Manufacturing jobs are open in Oxford, United Kingdom right now?
There are currently 85 open manufacturing positions in Oxford, United Kingdom listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Manufacturing roles in Oxford, United Kingdom?
Companies currently hiring include Oxford Nanopore Technologies, Moderna, Baxter International Inc., OrganOx, OXB, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Manufacturing jobs in Oxford, United Kingdom?
Yes — 37 of the 85 open manufacturing positions offer remote or hybrid work (1 remote, 36 hybrid).
How do I apply for Manufacturing jobs in Oxford, United Kingdom?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.