Oxford Nanopore Technologies

Quality Engineer - Software Development

Oxford Nanopore Technologies  •  Oxford, GB (Hybrid)  •  1 day ago
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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:

  • 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

You will have authority to review and approve D&D processes and records.

About You

Essential:

  • 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

Desirable:

  • Medical device or IVD experience
  • Internal Auditor training (ISO 9001/13485)
  • Validation experience (statistical, process or CSV)

Join us and help ensure the quality and compliance of technologies transforming genomics and diagnostics worldwide.

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.

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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

About Oxford Nanopore Technologies

Our goal is to enable the analysis of anything, anywhere, by anyone.

We have developed the world’s first and only nanopore DNA and RNA sequencing platform. It’s a new generation of sequencing technology — the only one to offer: scalability to portable or ultra-high throughput formats, real-time data delivery, and the ability to elucidate rich biological data.

We are aiming to disrupt the way that biological analyses are currently performed, and open up new applications that have a profound, positive impact on society.

Our devices offer real-time analysis, for rapid insights, in fully scalable formats — from pocket to population scale — and the technology is being used in more than 100 countries worldwide.

Founded in 2005 as a spin-out from the University of Oxford, the company now employs more than 600 people from multiple disciplines including nanopore science, molecular biology and applications, informatics, engineering, electronics, manufacturing and commercialisation. The management team, led by CEO Dr Gordon Sanghera, has a track record of delivering disruptive technologies to the market.

Industry
Biotech & Life Sciences
Company Size
1,001-5,000 employees
Headquarters
Oxford, GB
Year Founded
Unknown
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