Quality Systems Specialist
Oxford, UK, Hybrid
Oxford Nanopore Technologies (ONT) develops and manufactures innovative nanopore-based sequencing technologies for global research, biopharma, and IVD markets. Operating under ISO 13485 and ISO 9001 quality management systems, ONT ensures compliance with global regulatory requirements.
A sub-team of the QARA department, the Quality Systems team is responsible for ensuring that systems and processes are integrated across all departments and projects, promoting consistency and continuous improvement across the firm.
The Quality Assurance Specialist is responsible for the review and approval of key quality system records and activities within the Quality Management System (QMS), ensuring compliance with internal procedures and applicable regulatory standards (including ISO 13485 and ISO 9001).
In addition, the role is accountable for driving end-user adoption and effective utilisation of the company’s electronic QMS (eQMS), and for increasing quality awareness across the organisation. The post holder will lead initiatives to improve engagement, understanding, and consistency in the application of quality processes.
The role acts as a quality gatekeeper, QMS adoption lead, and quality culture champion, providing both operational oversight and organisational influence.
Key Responsibilities
Quality Event Review and Approval
- Review and approve Change Control and Deviation requests, Nonconformance reports, CAPA records
- Critically assess Root Cause Analysis, Risk Assessments, proposed corrective and preventive actions
- Ensure timely progression and closure of quality events
- Escalate significant quality or compliance risks
eQMS Adoption and User Engagement
- Act as the lead for end-user adoption of the eQMS (e.g. MasterControl)
- Develop and maintain training materials, user guides and support resources
- Deliver or coordinate training to drive effective system use
- Design, initiate, and manage user feedback mechanisms (e.g. surveys)
Quality Awareness and Culture Development
- Lead initiatives to increase quality awareness across the organisation
- Plan and organise Quality Week and engagement events
- Develop and streamline GxP training materials to improve accessibility and effectiveness
- Draft and deliver QA communications, updates and newsletters
QA SharePoint and Knowledge Management
- Own and manage the QA SharePoint site as a central hub for quality communication and resources
- Maintain and update content for organisation-wide audiences (e.g. newsletters, announcements, awareness content) and internal QA users (e.g. quality records, guidance, process resources)
- Ensure content is accurate, structured, accessible, and kept up to date
- Continually improve site usability and effectiveness as a communication and knowledge platform
Other
- Identify and report any quality or compliance concerns
- Be aware of and comply with the Quality Manual, Quality Management System, Quality Policy, Quality Goals and applicable regulations as they apply to this job type/position
- Provide QA guidance and constructive challenge to ensure compliance
- Influence behaviours and promote best practices across the organisation
- Provide expert guidance to stakeholders on QMS processes
- Any other duties as might be required within the remit and responsibilities of the post
About You
Qualifications/ Education:
- B.Sc. Degree in a relevant STEM discipline or equivalent relevant experience
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ISO 9001 or ISO 13485 Internal auditor training is desirable
Experience:
At least 3 years experience in a Quality Assurance role within a regulated environment
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Experience reviewing and approving Change Controls, CAPAs, Deviations, Nonconformances
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Experience developing training content and driving QMS adoption
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Experience managing or contributing to internal communications (e.g. newsletters, SharePoint, awareness initiatives)
Knowledge/Skills/Abilities:
Ability to critically assess investigations and challenge effectively
Strong written communication skills (training, newsletters, user content)
Ability to influence stakeholders and drive behavioural change
Strong organisational and information management skills
Analytical mindset (e.g. using feedback to improve systems and engagement)
Attitude/Other Requirements:
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Proactive and self-motivated
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Positive and collaborative team attitude
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Ability to prioritise tasks and manage multiple activities
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Ability to work independently in a fast-paced and changeable environment
Join us and help ensure the quality and compliance of technologies transforming genomics and diagnostics globally.
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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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.
Skills Required
- B.Sc. in a relevant STEM discipline or equivalent relevant experience
- At least 3 years' experience in a Quality Assurance role within a regulated environment
- Experience reviewing and approving Change Controls, CAPAs, Deviations and Nonconformances
- Experience driving QMS/eQMS adoption and developing training content
- Experience managing internal communications and QA knowledge platforms (e.g., SharePoint)
- Ability to critically assess investigations and challenge effectively (root cause analysis, risk assessments)
- Strong written communication skills for training materials, newsletters and user guides
- Ability to influence stakeholders and drive behavioural change
- Strong organisational and information management skills; analytical mindset
- Experience with eQMS software (e.g., MasterControl) or similar systems
- ISO 9001 or ISO 13485 Internal Auditor training
Oxford Nanopore Technologies Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Oxford Nanopore Technologies and has not been reviewed or approved by Oxford Nanopore Technologies.
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Fair & Transparent Compensation — Pay is considered good to above average across many roles, with employer-provided ranges visible for several U.S. commercial and applications positions and company materials emphasizing market‑competitive base pay. Commercial and some senior technical posts, particularly in the U.S., are positioned as competitive and often paired with strong variable components.
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Equity Value & Accessibility — All‑employee share plans in the UK and a U.S. employee stock purchase plan indicate broad access to equity as part of total reward. Company communications highlight attractive bonus and share plans that add meaningful upside beyond base pay.
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Healthcare Strength — U.S. roles indicate strong health insurance and core protections, while official materials and country overviews reference private medical coverage and wellbeing support. These elements position the health package as a notable strength alongside cash compensation.
Oxford Nanopore Technologies Insights
What We Do
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.
