Manufacturing Quality Manager

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

Job summary

A leading company in the field of gene-sequencing technology is seeking a Manufacturing Quality Manager to oversee QA and QC functions across multiple production sites. The role involves managing a team, ensuring compliance with ISO standards, and fostering a quality culture. Ideal candidates will have extensive experience in production quality management within electronics and cleanroom processes.

Qualifications

• At least 10 years managing a production quality team in electronics.
• Experience with quality assurance management across PCB manufacture.

Responsibilities

• Manage QA and QC functions across UK manufacturing sites.
• Ensure achievement of annual objectives and maintenance of ISO accreditation.

Skills

Interpersonal Skills

Organizational Skills

Influencing Skills

Education

HND in relevant science or engineering

Job description

This job is brought to you by Jobs/Redefined, the UK's leading over-50s age inclusive jobs board.

Job Description

Job Summary

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. The firm markets research use only applications and IVD instruments, developing its own assays and reagents, and collaborates with third parties. Based in Oxford, the products are marketed globally, subject to various regulations, and managed under two Quality Management Systems (ISO 13485-OND & ISO 9001-ONT).

The firm is expanding its quality function and aims to create a subteam of QA and QC staff focused on its four production sites. This role will manage the QA (2 heads) and QC (Lead and 2 heads) functions, reporting to the Snr Director of QA. Responsibilities include supporting all production and operations quality management activities, resource and facilities management, process control, validation, material specifications, inspections, internal and external audits, KPI development, non-conformance management, data analysis, CAPA, change control, and Certificate of Conformance activities.

The Manufacturing Quality Manager will support the Snr Director of QA in ensuring compliance with quality obligations and supporting the QMS and wider quality functions.

Key Responsibilities

The postholder will develop strong relationships with production teams and foster a quality culture across production sites. They will have authority to review and approve all production-related processes, documents, and records.

Duties

• Act as local manager for all QA and QC functions across UK manufacturing sites, supporting and deputising for the Snr Dir of QA.
• Ensure achievement of annual objectives and maintenance of ISO 9001 & 13485 accreditation.
• Establish and maintain strong working relationships with manufacturing teams.
• Support internal and external audits.
• Perform other duties as required.

Qualifications/Education

Essential

• HND level or higher in relevant science or engineering (electronics or mechanical).
• Qualified lead auditor (desirable).

Experience

Essential

• At least 10 years managing a production quality team in electronics and cleanroom processes within ISO 9001, 13485, or similar environments.
• Experience with quality assurance management across PCB manufacture, wiring, QC of metalwork, labelling, PCBAs, chemical supplies, wet processes, injection moulding, overmoulding, and robotic production.
• Understanding of electronic devices, software devices, assays, reagents, packaging, manufacturing, labelling, risk, and change management.
• Team management experience with teams larger than 5 members.
• Experience monitoring performance and driving QMS improvements through data analysis.

Desirable

• Experience in the IVD devices industry is advantageous.
• Experience with CE audits, FDA inspections, process validation, control, and traceability.
• Knowledge of wafer chip manufacturing and process risk management (PFMEA).

Knowledge/Skills/Abilities/Behaviours

• Deep knowledge of ISO standards (9001, 13485).
• Experience working with external partners, demonstrating discretion and sensitivity.
• Excellent interpersonal and organizational skills, with the ability to influence at senior levels.

Attitude/Other Requirements

• Positive, flexible, goal-oriented, and solution-focused attitude.
• Effective communicator in English, with high attention to detail and risk-based prioritization.

About Us

Oxford Nanopore aims to enable society to analyze anything, anywhere, using nanopore sensing technology. Founded in 2005 as a spin-out from the University of Oxford, it employs over 1000 people worldwide and impacts research and diagnostics globally.