Senior Quality Engineer - Med Device, Data-Driven Leader

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

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.