Senior Production Quality Engineer

Oxford Nanopore Technologies Ltd

Greater London

On-site

GBP 65,000 - 85,000

Full time

5 days ago
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Benefits offered by this job

Attractive bonus
Generous pension contributions
Private healthcare
Excellent starting salary

Job summary

Oxford Nanopore Technologies Ltd is seeking a Senior Production Quality Engineer to own the quality narrative on the shop floor and in the lab, bridging Engineering, Production and Supply Chain. You will lead investigations, standardise inspection processes, and drive risk mitigation and continuous improvement across the production landscape.

The role requires hands-on knowledge of ISO 13485 and CAPA/NCR management, plus the ability to coach teams of 2–20 people.

Qualifications

  • Degree in Mechanical Engineering or closely related discipline.

Responsibilities

  • Lead investigations of NCRs and CAPAs from initiation to verification using structured root-cause analysis.
  • Define, document and standardise goods-in inspection processes with clear acceptance criteria.
  • Participate in DFMEA/PFMEA and review drawings to ensure clarity and inspectability.
  • Analyse quality data to identify trends and lead change control activities (BOM and work instructions).
  • Maintain audit-readiness and participate in internal/external audits (ISO 13485).

Skills

Quality engineering
CAPA/NCR management
Root cause analysis
ISO 13485
ISO 14971
DFMEA/PFMEA
Risk assessment
Drawing interpretation
Team collaboration

Education

Mechanical Engineering degree
Lean Six Sigma Green Belt
ISO 13485 Lead/Internal Auditor

Job description

Senior Production Quality Engineer

2026-07-07T00:00:00

South East England

GB

KT19 8GY

Any

2026-10-10T14:51:39.2

Job Description

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.

Senior Production Quality Engineer

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.

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.

About Oxford Nanopore Technologies

Our goal is to bring the widest benefits to society through enabling the analysis of anything, by anyone, anywhere. The company has developed a new generation of nanopore-based sensing technology for faster, information-rich, accessible and affordable molecular analysis. The first application is DNA/RNA sequencing, and the technology is in development for the analysis of other types of molecules including proteins. The technology is used to understand and characterise the biology of humans and diseases such as cancer, plants, animals, bacteria, viruses, and whole environments. With a thriving culture of ambition and strong innovation goals, Oxford Nanopore is a UK headquartered company with global operations and customers in more than 125 countries.

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