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Oxford Nanopore Technologies (ONT) and its subsidiary Oxford Nanopore Diagnostics (OND) develop, manufacture, and sell products based on ONT’s nanopore-based next generation gene-sequencing (NGS) technology. The company markets its products globally, including research use only (RUO) and IVD markets, and operates under two Quality Management Systems (ISO 13485-OND & ISO 9001-ONT).
Job Summary
The Manufacturing Quality Manager will oversee the QA and QC functions across four production sites, managing a team that includes two QA heads and four QC staff. Reporting to the Senior Director of QA, the role involves ensuring compliance with quality standards, supporting the QMS, and fostering a quality-centric culture within manufacturing.
Key Responsibilities
* Manage all QA and QC activities at UK manufacturing sites, supporting the Senior Director of QA.
* Ensure achievement of quality objectives and maintenance of ISO 9001 & 13485 accreditation.
* Develop strong relationships with manufacturing teams and support internal/external audits.
* Review and approve processes, documents, and records related to production.
Qualifications & Experience
* HND or higher in relevant science or engineering field.
* Qualified lead auditor (desirable).
* Minimum 10 years managing production quality teams in ISO 9001, 13485, or similar environments, with experience across electronics, cleanroom processes, and related manufacturing areas.
* Experience with quality assurance in electronic devices, software, chemical reagents, and manufacturing processes.
* Proven leadership of teams >5 members and experience in data-driven quality management.
Knowledge, Skills & Behaviours
* Deep understanding of ISO standards (e.g., 9001, 13485).
* Strong stakeholder management and interpersonal skills.
* Ability to influence at senior levels and develop solutions in fast-paced environments.
About Us
Oxford Nanopore aims to enable accessible, real-time analysis of DNA and RNA globally, with a technology used in over 100 countries. Founded in 2005, the company employs over 1,000 staff worldwide.
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