Quality Engineer - Microfluidics & Chemistry

Quality Engineer – Microfluidics & Chemistry

Oxford, UK, Hybrid

Oxford Nanopore Technologies (ONT are global leaders in nanopore-based next generation sequencing technology, delivering innovative research and IVD products worldwide.

We are seeking a Quality Engineer – Microfluidics & Chemistry to support our flow cell and chemistry product portfolio, ensuring robust quality and compliance across design, development, and production transfer.

The Role

Duties include, but are not limited to:

• Support design control activities across microfluidic systems, flow cells and chemical/reagent products
• Ensure compliance with ISO 9001 / ISO 13485 and internal Quality Systems
• Review and approve Design & Development and Change Control documentation
• Support Verification & Validation (V&V) planning, execution and traceability
• Partner with R&D, Manufacturing, Technical Transfer and Regulatory Affairs
• Contribute to risk management, CAPA and non-conformance activities
• Support lifecycle design changes and technical impact assessments

You will have authority to review and approve relevant D&D processes and records.

About You

Essential:

• BSc in Engineering, Chemistry or relevant Scientific discipline (or equivalent experience)
• 5 plus years’ experience in Design/Development or QA within an ISO 9001 or ISO 13485 regulated environment
• Strong understanding of design controls, V&V, risk management and traceability
• Experience with microfluidics, reagent/chemical products, biological components or similar technologies
• Working knowledge of DMS, Change Control and CAPA systems

Desirable:

• Medical device or IVD experience
• ISO 9001 / ISO 13485 Internal Auditor training
• Validation experience (statistical, process or computer systems validation)

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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