Quality Engineer - Software Development
UK Visa Sponsorship Analytics
Occupation Type
Programmers and software development professionals
Occupation Code Skill LevelHigher Skilled
Sponsorship Salary Threshold
£54,700
(£28.05 per hour)
Occupation rate applies
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Description
Job Description
QA Engineer – Software Development
Oxford, UK, Hybrid
Oxford Nanopore Technologies (ONT) are global leaders in nanopore-based next generation sequencing technology, developing innovative research and IVD products used worldwide.
We’re looking for a QA Engineer – Software Development to support design control activities across flow cells, chemical components and reagent-based products, ensuring compliant development through to production transfer.
The Role
Duties Include, But Are Not Limited To
Essential
QA Engineer – Software Development
Oxford, UK, Hybrid
Oxford Nanopore Technologies (ONT) are global leaders in nanopore-based next generation sequencing technology, developing innovative research and IVD products used worldwide.
We’re looking for a QA Engineer – Software Development to support design control activities across flow cells, chemical components and reagent-based products, ensuring compliant development through to production transfer.
The Role
Duties Include, But Are Not Limited To
- Support design planning, requirements traceability and documentation review
- Oversee Verification & Validation (V&V) planning and execution
- Partner with R&D, Technical Transfer, Manufacturing and Regulatory Affairs
- Contribute to risk management activities
- Review and approve Design & Development and Change Control documentation
- Support CAPA, non-conformance and Quality System processes
- Ensure compliance with ISO 9001 / ISO 13485, GMP, GLP and GDP
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.
- BSc in Engineering or relevant Scientific discipline (or equivalent experience)
- 5+ years’ experience in Design/Development or QA within an ISO 9001 / ISO 13485 regulated environment
- Strong understanding of design controls, V&V, risk management and traceability
- Experience with design and development of software and firmware products, including software product lifecycle management.
- Working knowledge of DMS, Change Control and CAPA systems
- Medical device or IVD experience
- Internal Auditor training (ISO 9001/13485)
- Validation experience (statistical, process or CSV)
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.