Manufacturing Quality Manager

Oxford Nanopore Technologies; Abingdon; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading biotechnology firm in Abingdon is seeking a QA/QC Manager to oversee quality management across multiple production sites. The ideal candidate will have over 10 years of experience in managing production quality in regulated sectors like medical devices and will be responsible for maintaining ISO 9001 and 13485 compliance. Key skills include stakeholder management and strong communication capabilities in a fast-paced environment.

Qualifications

• Minimum of 10 years' experience in a regulated environment.
• Experience in cleanroom and electronics manufacturing.
• Demonstrated team leadership with teams of more than 5.

Responsibilities

• Manage all QA and QC functions across UK manufacturing sites.
• Act as senior deputy to the Senior Director of QA.
• Support internal and external audits.

Skills

Management of production quality team

ISO 9001 & 13485 knowledge

Stakeholder management

Interpersonal skills

Education

HND or higher in science or engineering

Job description

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Job Description

About Us

Oxford Nanopore Technologies (ONT) and its subsidiary Oxford Nanopore Diagnostics (OND) develop, manufacture, and sell products based on ONT's unique and market-leading nanopore-based next-generation gene-sequencing (NGS) technology. Our products support both research use and IVD applications, and we also collaborate with a wide range of third parties for assay development. With design and manufacturing based in Oxford and global marketing, our IVD instruments and assays are subject to international regulations. OND and ONT operate two Quality Management Systems: ISO 13485 (OND) and ISO 9001 (ONT).

The Role

As part of our expanding quality function, we\'re establishing a dedicated QA and QC team focused on our four production sites in Abingdon and Harwell. This role manages both QA (2 heads) and QC (1 Lead and 2 heads), reporting directly to the Senior Director of Quality Assurance. You\'ll be responsible for supporting overall Production/Operations Quality Management across resources, facilities, environmental conditions, process control, validation, material specifications, inspections, internal/external audits, CAPA, change control, and certificate of conformance activities.

You will also

• Provide primary support to the Senior Director of QA in managing and executing the QMS.
• Develop deep relationships with production functions and foster a strong quality culture.
• Review and approve all production-related processes, documents, and records.

Key Responsibilities

• Manage all QA and QC functions across UK direct manufacturing sites.
• Act as senior deputy to the Senior Director of QA, representing them in Production-related matters.
• Support the Production QA & QC team in achieving objectives and maintaining ISO 9001 & 13485 accreditation.
• Establish strong relationships with manufacturing teams.
• Support or lead internal and external audits (regulatory, customer, certification).
• Perform any other reasonable duties as required.

PERSON SPECIFICATION

Essential Qualifications & Experience

• HND or higher in a relevant science or engineering discipline (e.g., electronics or mechanical).
• A minimum of 10 years\' experience managing a production quality team across electronics and cleanroom environments within ISO 9001, 13485, or similar regulated sectors (medical device, aerospace, pharma, etc.).

Experience with:

• PCB, loom/wiring manufacturing
• QC (metalwork, labelling, PCBAs, chemical supplies, etc.)
• Wet processes, injection/overmoulding
• Robotic/computer-controlled production
• Understanding of electronic/software devices, SaMD, reagents, packaging, labelling, risk/change management.
• Demonstrated team leadership (teams of >5) and performance monitoring.
• Strong grasp of quality principles in complex manufacturing settings.
• Deep knowledge of process validation, control, traceability of records/materials.

Desirable

• Lead auditor qualification (ISO 13485/IVD).
• CE audit/FDA inspection experience.
• Experience with wafer chip manufacturing.
• Understanding of process risk management (PFMEA).

Skills & Abilities

• Detailed working knowledge of ISO 9001 or ISO 13485.
• Strong external stakeholder management with a balanced risk/commercial approach.
• Excellent interpersonal and organisational skills.
• Influential communicator at senior levels.

Attitude & Requirements

• Goal-oriented, solution-focused, and adaptable in fast-paced, agile environments.
• Highly effective communicator to non-expert groups.
• Excellent written and spoken English.
• High attention to detail with risk-based prioritisation

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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.