Senior Quality Assurance Engineer

Aurora Life Sciences; Leeds; On-site; GBP 65,000 - 90,000; Full time

Job summary

Aurora Life Sciences is seeking a Senior Quality Engineer for a hands-on principal role across Quality, Engineering and Manufacturing in a growing medical device environment.

The successful candidate will lead validation, non-conformance investigations, CAPA, risk management and PFMEA, and will embed quality into day-to-day operations.

You will mentor engineers, review production records and ensure compliance with QSR, ISO 13485 and 21 CFR Part 820 while driving data‑driven continuous improvement.

Qualifications

• 4+ years of experience in medical devices.
• Strong knowledge of ISO 13485, ISO 14971 and 21 CFR Part 820.
• Experience in non-conformance investigations, root cause analysis, CAPA and risk management.
• Ability to use data to drive decisions and continuous improvement.

Responsibilities

• Lead investigations, validation activity and cross-functional improvement projects.
• Partner with manufacturing and process engineering teams to develop, qualify and optimise robust processes.
• Use data, trend analysis and structured problem-solving to identify variation, failure modes and opportunities for process improvement.
• Create, review and approve IQ/OQ/PQ protocols, reports, Gage R&R studies and supporting validation documentation.
• Provide technical oversight for design verification, design changes and technical risk assessments.
• Lead PFMEA, risk management and root cause activity, ensuring corrective actions address systemic causes rather than symptoms.
• Review production records and manufacturing documentation to ensure compliance with QSR and ISO requirements.
• Lead investigations into NCRs, CAPAs, complaints and manufacturing-related quality events.
• Audit manufacturing processes, internal systems and suppliers, translating findings into measurable process improvement.
• Support the Validation Master Plan and ensure validation activity is proportionate, risk-based and commercially pragmatic.
• Lead continuous improvement initiatives, using evidence and process capability data to drive decisions.
• Mentor less experienced engineers and raise the technical standard of Quality Engineer practice across the team.
• Maintain a strong presence within manufacturing, ensuring quality requirements are understood, practical and embedded into day-to-day operations.

Skills

Quality engineering

Data analysis

CAPA

Risk management

Validation

Root cause analysis

ISO 13485

Manufacturing support

Education

Engineering degree

Tools

Gage R&R

PFMEA

CAPA software

Job description

The Opportunity

We are seeking a highly capable Senior Quality Engineer to take a principal-level role within a growing medical device environment. This is a hands‑on position for someone who combines technical depth with pragmatism, uses data to drive decisions, and can turn complex quality issues into practical, sustainable improvement.

The Senior Quality Engineer will operate across Quality, Engineering and manufacturing, providing technical leadership on validation, non‑conformance, risk, design change and continuous improvement. Success in this role will come from being visible, decisive and comfortable challenging the status quo.

Key Responsibilities

• Act as the lead Quality Engineer for complex investigations, validation activity and cross‑functional improvement projects.
• Partner with manufacturing and process engineering teams to develop, qualify and optimise robust processes.
• Use data, trend analysis and structured problem‑solving to identify variation, failure modes and opportunities for process improvement.
• Create, review and approve IQ/OQ/PQ protocols, reports, Gage R&R studies and supporting validation documentation.
• Provide technical oversight for design verification, design changes and technical risk assessments.
• Lead PFMEA, risk management and root cause activity, ensuring corrective actions address systemic causes rather than symptoms.
• Review production records and manufacturing documentation to ensure compliance with QSR and ISO requirements.
• Lead investigations into NCRs, CAPAs, complaints and manufacturing‑related quality events.
• Audit manufacturing processes, internal systems and suppliers, translating findings into measurable process improvement.
• Support the Validation Master Plan and ensure validation activity is proportionate, risk‑based and commercially pragmatic.
• Lead continuous improvement initiatives, using evidence and process capability data to drive decisions.
• Mentor less experienced engineers and raise the technical standard of Quality Engineer practice across the team.
• Maintain a strong presence within manufacturing, ensuring quality requirements are understood, practical and embedded into day‑to‑day operations.

Experience & Technical Requirements

• Degree in Engineering, Science or a relevant technical discipline.
• 4+ years' experience within medical devices
• Strong working knowledge of ISO 13485, ISO 14971 and 21 CFR Part 820 / QMSR requirements.
• Demonstrable experience in non‑conformance investigation, root cause analysis, CAPA, risk management and validation.
• Strong understanding of process capability, inspection, measurement systems and process improvement methodologies.
• Proven ability to use data to influence technical and operational decisions within manufacturing.

What We Need

This role requires a Quality Engineer who is pragmatic, commercially aware and technically credible. You will be expected to make sound decisions with incomplete information, prioritise what matters, challenge weak process thinking and drive meaningful process improvement.

The right Quality Engineer will be comfortable moving between the detail and the bigger picture: solving today's problems while strengthening systems for future growth.

Please note: only applications from candidates with experience in the medical device or life sciences sectors will be considered