Associate Director, Quality Assurance

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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 its technologies and products for research use only (RUO) and IVD instruments, which are subject to regulations in various territories. ONT operates two Quality Management Systems (ISO 13485-OND & ISO 9001-ONT) to ensure compliance.

Reporting to the Head of QA, the Associate Director of Quality Assurance is responsible for ensuring full compliance with quality obligations, supporting the management and execution of the QMS, and leading the quality team and functions.

Key Responsibilities

The postholder will lead and support the quality team and related processes, reviewing and approving all processes, documents, and records.

Duties

Responsibilities include, but are not limited to:

1. Acting as support and senior deputy to the Head of QA.
2. Ensuring achievement of annual objectives and maintaining ISO9001 & 13485 accreditation, including regulatory compliance roles such as EU IVDR.
3. Building strong cross-functional relationships to facilitate best practices in risk management, product development, manufacturing, and post-market surveillance.
4. Supporting internal and external audits (customer, regulatory, certification).
5. Performing other reasonable duties as required.

Qualifications

BSc or higher in engineering (electronics or software) or a scientific field, or proven relevant quality management experience. Lead auditor qualification is desirable.

Experience

Minimum 10 years managing a full lifecycle quality management team in the IVD industry, with expertise in electronic devices, software devices, assays, reagents, manufacturing, and risk management. Experience with ISO 13485, MDSAP, and leading certification audits is essential. Desirable experience includes FDA inspections, recalls management, and computer systems validation.

Knowledge/Skills/Abilities

Deep knowledge of ISO13485, MDSAP, IVDR, and related standards. Strong stakeholder management, regulatory understanding, and ability to simplify complex standards for team implementation. Excellent interpersonal, organizational, and influencing skills at senior levels.

Attitude/Behaviours/Other

Positive, flexible, goal-oriented, and capable of working in fast-paced environments. Effective communicator with high attention to detail and risk prioritization skills.

About Us

Oxford Nanopore aims to enable society-wide analysis of biological and environmental samples using innovative nanopore technology. Founded in 2005 as a University of Oxford spin-out, it now employs over 1000 people globally.

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