Senior Production Quality Engineer
Oxford Nanopore Technologies is a global biotechnology company pioneering nanopore-based sensing technology that enables the analysis of DNA, RNA and other molecules. Our mission is to bring the widest benefits to society by enabling the analysis of anything, by anyone, anywhere!
Headquartered in the UK and serving customers in over 125 countries, we are transforming scientific discovery and advancing research across human health, cancer, infectious diseases, agriculture and environmental science.
We are looking for a Senior Production Quality Engineer to become our team's go-to production quality champion. In this role, you won't just be managing paperwork-you will be the bridge between Engineering, Production, and Supply Chain, driving root-cause investigations, closing capability gaps, and embedding a proactive, gold-standard quality culture across our entire production landscape.
The Role….
As our Senior Production Quality Engineer, you will own the quality narrative on the shop floor and in the lab. Your day-to-day will involve:
- Leading Investigations: Take full ownership of internal and supplier NCRs and CAPAs from initiation to verification, using structured root-cause analysis (5-Why, Fishbone, etc.).
- Standardising Excellence: Define, document, and standardise our goods-in inspection processes, creating clear acceptance/rejection criteria and training the inspection teams to execute them flawlessly.
- Mitigating Risk Early: Participate heavily in risk assessment activities (DFMEA/PFMEA) and review engineering drawings to ensure everything is clear, robust, and inspectable.
- Driving Continuous Improvement: Analyse quality data to spot trends, eliminate systemic defects, and lead change control activities (including BOM and work instruction updates).
- Auditing & Compliance: Keep us sharp and audit-ready, actively participating in internal and external audits (including ISO 13485).
What We Are Looking For….
We need someone who understands the rigor of regulated manufacturing but possesses the soft skills to coach, mentor, and constructively challenge existing practices.
Essentials:
- A degree in Mechanical Engineering (or a closely related discipline).
- Proven track record in a Quality Engineering or Manufacturing Quality role, ideally working with electromechanical devices.
- Hands-on working knowledge of ISO 13485 and ISO 14971.
- Expertise in structured problem-solving (CAPA/NCR management) and the ability to interpret engineering drawings and risk documentation.
- A proactive, collaborative team player who can manage multiple moving parts, drive investigations forward, and work effectively in teams of 2 to 20 people.
Desirables:
- A formal qualification in Quality or a Lean Six Sigma Green Belt.
- An ISO 13485 Lead or Internal Auditor certification.
- Experience specific to the medical device industry.
- A knack for mentoring others and a strong grasp of statistical quality tools.
Why Join Us?
This isn't a role where you will be an invisible cog in a massive machine. You will report directly to the Associate Director of Production Engineering, giving your work high visibility and real strategic weight. You will have the autonomy to build out processes, coach teams, and directly influence the reliability of life-changing products.
We offer outstanding benefits to include an attractive bonus, generous pension contributions, private healthcare and an excellent starting salary.
If you are looking to utilise your skills to really make a difference to humankind, then consider joining our team and apply today!
Please note that no terminology in this advert is intended to discriminate on the grounds of a person's gender, marital status, race, religion, colour, age, disability or sexual orientation. Every candidate will be assessed only in accordance with their merits, qualifications and abilities to perform the duties of the job.