Quality Engineer - Microfluidics & Chemistry
UK Visa Sponsorship Analytics
Occupation Type
Quality assurance technicians
Occupation Code Skill LevelMedium Skilled
Sponsorship Salary Threshold
£41,700
(£21.38 per hour)
Standard minimum applies
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Description
Job Description
Quality Engineer – Microfluidics & Chemistry
Oxford, UK, Hybrid
Oxford Nanopore Technologies (ONT are global leaders in nanopore-based next generation sequencing technology, delivering innovative research and IVD products worldwide.
We are seeking a Quality Engineer – Microfluidics & Chemistry to support our flow cell and chemistry product portfolio, ensuring robust quality and compliance across design, development, and production transfer.
The Role
Duties Include, But Are Not Limited To
Quality Engineer – Microfluidics & Chemistry
Oxford, UK, Hybrid
Oxford Nanopore Technologies (ONT are global leaders in nanopore-based next generation sequencing technology, delivering innovative research and IVD products worldwide.
We are seeking a Quality Engineer – Microfluidics & Chemistry to support our flow cell and chemistry product portfolio, ensuring robust quality and compliance across design, development, and production transfer.
The Role
Duties Include, But Are Not Limited To
- Support design control activities across microfluidic systems, flow cells and chemical/reagent products
- Ensure compliance with ISO 9001 / ISO 13485 and internal Quality Systems
- Review and approve Design & Development and Change Control documentation
- Support Verification & Validation (V&V) planning, execution and traceability
- Partner with R&D, Manufacturing, Technical Transfer and Regulatory Affairs
- Contribute to risk management, CAPA and non-conformance activities
- Support lifecycle design changes and technical impact assessments
You will have authority to review and approve relevant D&D processes and records.
Essential
About You
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.
Essential
About You
- BSc in Engineering, Chemistry or relevant Scientific discipline (or equivalent experience)
- 5 plus years’ experience in Design/Development or QA within an ISO 9001 or ISO 13485 regulated environment
- Strong understanding of design controls, V&V, risk management and traceability
- Experience with microfluidics, reagent/chemical products, biological components or similar technologies
- Working knowledge of DMS, Change Control and CAPA systems
- Medical device or IVD experience
- ISO 9001 / ISO 13485 Internal Auditor training
- Validation experience (statistical, process or computer systems validation)
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 Us
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.
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.