Quality Assurance Specialist – Design & Development (Electronics)

Quality Assurance Specialist Design & Development (Electronics)
HybridOxford UK Oxford Nanopore Technologies

Oxford Nanopore Technologies (ONT) and its subsidiary Oxford Nanopore Diagnostics (OND) develop and manufacture market-leading nanopore-based next generation sequencing (NGS) technologies used across research biopharma and in-vitro diagnostics (IVD). Designed and manufactured in Oxford and used globally our products operate within regulated environments supported by ISO 13485 and ISO 9001 Quality Management Systems.

We are seeking a Quality Assurance Specialist Design & Development to support quality activities across the development lifecycle of our electronic products. Reporting to the QA Manager NPI this role ensures design control risk management and development processes are compliant and that products meet performance safety and regulatory requirements through to transfer into production.

You will collaborate closely with teams across R&D technical transfer manufacturing product management and regulatory affairs to support compliant product development and lifecycle management.

Key Responsibilities

• Support QA activities across design and development processes
• Review and approve Design & Development and Change Control documentation
• Ensure compliance with design controls verification & validation (V&V) and traceability
• Participate in risk management and regulatory collaboration
• Support lifecycle design changes and verification/validation planning
• Maintain Quality System documentation CAPA and quality metrics
• Provide guidance on Document Management Systems and quality processes
• Support continuous improvement training and management reviews

Essential Qualifications & Experience

• BSc in Engineering or Science (e.g. electronics microelectronics electro-mechanical engineering) or equivalent experience
• 5 years experience in product design/development or QA within a regulated environment (ISO 9001 or ISO 13485)
• Experience supporting electronic product development
• Strong understanding of design control principles including requirements verification validation and risk management
• Working knowledge of document control change management non-conformance and CAPA systems
• Familiarity with relevant technical standards (IEC ISO ASTM)

Desirable

• ISO 9001 or ISO 13485 Internal Auditor training
• Experience within medical device or IVD environments
• Knowledge of statistical process or computer systems validation
• Experience authoring requirements test protocols or verification reports

What Were Looking For

• Detail-oriented with a strong quality mindset
• Strong problem-solving and root cause analysis skills
• Comfortable working in a fast-paced collaborative environment
• Proactive with a continuous improvement mindset

Please note that no terminology in this advert is intended to discriminate on the grounds of a persons 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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