Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead quality engineering for life-saving medical devices and ensure top-notch product standards.
- Company: Join OrganOx, a pioneering medical device company dedicated to improving organ transplantation.
- Benefits: Enjoy competitive pay, healthcare, retirement plans, and a focus on work-life balance.
- Why this job: Make a real difference in healthcare while developing your skills in a dynamic environment.
- Qualifications: Experience in quality engineering within regulated industries and a relevant degree required.
- Other info: Flexible onsite role with opportunities for international travel and professional growth.
The predicted salary is between 48000 - 72000 ÂŁ per year.
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 Senior Product Quality Engineer develops and oversees product and device inspection and acceptance activities for the OrganOx Metra, a Class III medical device. Responsibilities include first article inspection processes, oversight of incoming inspection, non‑conforming material management, material review board, and product acceptance. The role works closely with contracted manufacturers, suppliers, and quality inspectors to ensure day‑to‑day execution of these critical business processes and leads improvements of these processes. It involves supervisory responsibilities of Quality Inspectors and Technicians and the execution of continuous improvement initiatives to improve product quality. This is an onsite position in Oxford with flexibility.
Major Responsibilities
- 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 (e.g., Investigation Aging, NC aging and resolution)
- Promote a culture of accountability, collaboration and continuous improvement.
- Technical Quality Engineering Oversight
- Hands‑on oversight of the device acceptance process, ensuring device acceptance targets are met.
- Hands‑on oversight of the incoming inspection process, ensuring inspection targets are met.
- Development of first article inspection processes
- 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 OrganOx’s 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.
- 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 non‑conformances, 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
- Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
- 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.
Senior Product Quality Engineer - Retained Unit employer: OrganOx
Contact Detail:
OrganOx Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Product Quality Engineer - Retained Unit
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical device industry, especially those who might know someone at OrganOx. A friendly chat can sometimes lead to insider info or even a referral.
✨Tip Number 2
Prepare for the interview by diving deep into OrganOx's products and mission. Knowing the ins and outs of the OrganOx metra® will show you're genuinely interested and ready to contribute to their life-saving work.
✨Tip Number 3
Practice your STAR technique for behavioural questions. Think of specific situations where you demonstrated leadership or problem-solving skills, especially in quality engineering contexts. This will help you shine during the interview!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re serious about joining the OrganOx team and making a difference in transplantation outcomes.
We think you need these skills to ace Senior Product Quality Engineer - Retained Unit
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Product Quality Engineer role. Highlight your relevant experience in quality engineering, especially within the medical device field. We want to see how your skills align with our mission at OrganOx!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about improving transplantation outcomes and how your background makes you a perfect fit for our team. Let us know what excites you about working with OrganOx.
Showcase Your Achievements: When detailing your experience, focus on specific achievements that demonstrate your problem-solving skills and ability to improve quality processes. We love numbers, so if you can quantify your successes, even better!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our innovative team at OrganOx!
How to prepare for a job interview at OrganOx
✨Know Your Stuff
Make sure you brush up on your knowledge of FDA regulations, ISO standards, and quality engineering principles. Being able to discuss these topics confidently will show that you're serious about the role and understand the industry.
✨Showcase Your Problem-Solving Skills
Prepare specific examples of how you've tackled quality issues in the past. Use the STAR method (Situation, Task, Action, Result) to structure your answers, highlighting your analytical skills and ability to drive continuous improvement.
✨Demonstrate Leadership Qualities
Since this role involves managing a team, be ready to discuss your leadership style and experiences. Share how you've motivated teams, managed performance reviews, and fostered a culture of accountability and collaboration.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's quality processes, team dynamics, and future projects. This not only shows your interest but also helps you gauge if the company culture aligns with your values.
