At a Glance
- Tasks: Ensure manufacturing processes meet quality standards and lead validation activities.
- Company: Join OrganOx, a pioneering organ technology company improving patient outcomes.
- Benefits: Competitive salary, flexible working, and opportunities for professional growth.
- Other info: Work in a dynamic environment with a focus on innovation and collaboration.
- Why this job: Make a real difference in healthcare by ensuring quality in life-saving technologies.
- Qualifications: Experience in quality engineering and validation processes required.
The predicted salary is between 40000 - 50000 € per year.
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). Its 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 Quality Engineer, Validation is responsible for ensuring that manufacturing processes and test methods are robust, repeatable, and capable of consistently meeting defined requirements. Working within the Product Quality team, the role leads process and test method validation activities across OrganOx and its suppliers. With a focus on providing Quality support for validation of new manufacturing processes (injection moulding, assembly, sterilisation, packaging), as well as sustaining existing processes at suppliers. It sits at the point where design intent is translated into controlled, reliable execution, in line with the principles of ISO 13485 and risk management expectations of ISO 14971.
By working closely with Design Assurance, Operations and Supplier the Validation Quality Engineer takes defined inputs, understands risk through tools such as pFMEA, and builds validation strategies that provide clear, objective evidence of performance. Validation activities are planned and executed in alignment with recognised guidance for process validation and measurement system analysis, ensuring outputs support design transfer and meet regulatory expectations. The role requires a practical, disciplined approach. It involves writing Validation planning and reporting documents (VMP, VSR), support defining validation activities with IQ, OQ and PQ phases, analysing data, and producing outputs that withstand audit and regulatory scrutiny. The Validation Engineer is expected to operate with a degree of independence, bringing enough experience to move work forward with clarity and purpose from the outset. This is an on-site position in Oxford, with flexibility.
Major Responsibilities
- Validation Planning and Execution
- Develop and maintain validation plans aligned to product and process risk
- Lead execution of process validation (IQ, OQ, PQ)
- Lead execution of test method validation (including MSA, Gage R)
Quality Engineer, Validation employer: OrganOx
OrganOx is an exceptional employer that fosters a collaborative and innovative work culture, dedicated to improving patient outcomes through cutting-edge organ technology. Located in Oxford, employees benefit from a vibrant academic environment, ample opportunities for professional growth, and the chance to contribute to meaningful advancements in healthcare. With a commitment to quality and excellence, OrganOx provides a supportive atmosphere where your expertise as a Quality Engineer can truly make a difference.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Engineer, Validation
✨Tip Number 1
Network like a pro! Reach out to current employees at OrganOx on LinkedIn or other platforms. Ask them about their experiences and any tips they might have for landing a role there. Personal connections can make a huge difference!
✨Tip Number 2
Prepare for the interview by understanding the company’s products and values. Dive deep into the metra® platform and how it impacts organ preservation. Showing genuine interest in what they do will set you apart from other candidates.
✨Tip Number 3
Practice your responses to common interview questions, especially those related to quality engineering and validation processes. Use the STAR method (Situation, Task, Action, Result) to structure your answers and highlight your relevant experience.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining the team at OrganOx.
We think you need these skills to ace Quality Engineer, Validation
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Engineer role. Highlight relevant experience in validation processes, ISO standards, and any specific skills that match the job description. We want to see how your background aligns with what we’re looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality engineering and how your skills can contribute to our mission at OrganOx. Keep it concise but impactful – we love a good story!
Showcase Your Problem-Solving Skills:In your application, don’t forget to showcase your problem-solving abilities. Share examples of how you've tackled challenges in past roles, especially those related to validation and process improvement. We’re all about finding solutions here!
Apply Through Our Website:We encourage you to apply through our website for the best chance of getting noticed. It’s super easy and ensures your application goes directly to us. Plus, you’ll get to see more about our culture and values while you’re there!
How to prepare for a job interview at OrganOx
✨Know Your Stuff
Make sure you understand the key concepts of validation processes, especially IQ, OQ, and PQ phases. Brush up on ISO 13485 and ISO 14971 standards, as these will likely come up in conversation. Being able to discuss how you've applied these principles in past roles will show you're a strong candidate.
✨Show Your Problem-Solving Skills
Prepare examples of how you've tackled challenges in previous projects, particularly those related to process validation or quality assurance. Use the STAR method (Situation, Task, Action, Result) to structure your answers, making it easy for the interviewer to follow your thought process.
✨Ask Smart Questions
Demonstrate your interest in the role by asking insightful questions about OrganOx's validation processes and how they align with their mission. Inquire about the team dynamics and how they collaborate with design assurance and operations. This shows you're not just interested in the job, but also in the company culture.
✨Be Ready to Discuss Data Analysis
Since the role involves analysing data and producing outputs that withstand audit scrutiny, be prepared to talk about your experience with data analysis tools and techniques. Highlight any specific software or methodologies you've used, and how they contributed to successful validation outcomes in your previous roles.
