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- 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: Opportunity for international travel and professional growth in a supportive team.
The predicted salary is between 42000 - 60000 £ 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. 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.
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 (Ex- Investigation Aging, NC aging and resolution)
- Promote a culture of accountability, collaboration and continuous improvement.
- Conducting hands on oversight 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
- 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.
- 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:
- 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:
- Bachelor’s 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.
Senior Product Quality Engineer - Retained Unit in Oxford employer: OrganOx
Contact Detail:
OrganOx Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Product Quality Engineer - Retained Unit in Oxford
✨Tip Number 1
Network like a pro! Reach out to folks in the medical device industry, especially those connected to OrganOx. LinkedIn is your best mate here; drop them a message and express your interest in the Senior Product Quality Engineer role.
✨Tip Number 2
Prepare for the interview by brushing up on your knowledge of FDA regulations and quality standards. We want you to show off your expertise in root cause analysis and continuous improvement initiatives during the chat!
✨Tip Number 3
Don’t just wait for job openings to pop up! Keep an eye on our website and apply directly through it. This shows your enthusiasm and commitment to being part of the OrganOx team.
✨Tip Number 4
Practice your evidence-based communication skills. You’ll need to demonstrate how you can effectively communicate with management and peers about quality processes and improvements. Role-play with a friend if you have to!
We think you need these skills to ace Senior Product Quality Engineer - Retained Unit in Oxford
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 great 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 to ensure your application gets into the right hands. Plus, it shows us you’re genuinely interested in 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. Familiarise yourself with OrganOx's products, especially the OrganOx metra system, so you can speak confidently about how your experience aligns with their mission.
✨Show Your Leadership Skills
Since this role involves managing a team, be prepared to discuss your leadership style and past experiences. Think of specific examples where you've successfully led a team or improved processes, and be ready to share how you promote accountability and collaboration.
✨Prepare for Technical Questions
Expect to dive deep into technical aspects during the interview. Brush up on root cause analysis, non-conformance management, and first article inspections. Be ready to discuss how you've used data analysis to solve quality issues in previous roles.
✨Ask Insightful Questions
At the end of the interview, have some thoughtful questions ready. Inquire about the company's approach to continuous improvement or how they handle regulatory compliance challenges. This shows your genuine interest in the role and helps you assess if it's the right fit for you.
