Senior Quality Engineer

Aurora Life Sciences; Leeds; On-site; GBP 55,000 - 75,000; Full time

Job summary

Aurora Lifesciences is seeking an experienced Senior Quality Engineer to join our medical device manufacturing team in Leeds. The role provides hands-on quality engineering support across manufacturing, validation, design changes, non-conformance investigations, risk management and continuous improvement.

You will lead CAPA/NCR investigations, drive root cause analysis, support process validation and design changes, and mentor junior engineers while promoting a culture of continuous improvement.

Qualifications

• 5+ years' Quality Engineering experience within medical devices manufacturing.
• Experience with CAPA, NCR, root cause analysis, investigations and corrective actions.
• Experience with IQ/OQ/PQ and process validation.
• Knowledge of ISO 13485, ISO 14971 and 21 CFR Part 820.

Responsibilities

• Lead investigations into NCRs, non-conformances, CAPAs and manufacturing quality issues.
• Drive root cause analysis and corrective/preventive actions using structured problem-solving techniques.
• Support manufacturing and engineering teams with process development, process optimisation and process qualification.
• Create, review and approve validation protocols and reports covering IQ/OQ/PQ, design verification, process validation and Gage R&R.
• Review and approve design changes and provide quality engineering input into new and existing manufacturing processes.
• Lead risk management, PFMEA and cross-functional improvement activities.
• Support internal and supplier audits and ensure manufacturing activities remain compliant with applicable procedures and standards.
• Support Quality System activities including NCRs, CAPAs and complaints.
• Mentor junior quality engineers and promote continuous improvement across Quality and Manufacturing.

Skills

CAPA

NCR handling

Root cause analysis

Investigations

Corrective actions

Process validation

IQ/OQ/PQ

Design changes

Risk management

Six Sigma / Lean Six Sigma

Project management

Cross-functional communication

Education

Engineering or relevant scientific degree

Tools

Gage R&R

Job description

Aurora Lifesciences are seeking an experienced Senior Quality Engineer to join a exciting medical device manufacturing team. The role will provide hands-on quality engineering support across manufacturing, validation, design changes, non-conformance investigations, risk management and continuous improvement.

Senior Quality Engineer – Key Responsibilities

• Lead investigations into NCRs, non-conformances, CAPAs and manufacturing quality issues.
• Drive root cause analysis and corrective/preventive actions using structured problem-solving techniques.
• Support manufacturing and engineering teams with process development, process optimisation and process qualification.
• Create, review and approve validation protocols and reports covering IQ/OQ/PQ, design verification, process validation and Gage R&R.
• Review and approve design changes and provide quality engineering input into new and existing manufacturing processes.
• Lead risk management, PFMEA and cross-functional improvement activities.
• Support internal and supplier audits and ensure manufacturing activities remain compliant with applicable procedures and standards.
• Support Quality System activities including NCRs, CAPAs and complaints.
• Mentor junior quality engineers and promote continuous improvement across Quality and Manufacturing.

Experience Required

• 5+ years' Quality Engineering experience within medical devices manufacturing environment.
• Strong experience of CAPA, NCR, root cause analysis, investigations and corrective actions.
• Experience of process validation, IQ/OQ/PQ and manufacturing quality engineering.
• Knowledge of ISO 13485, ISO 14971 and 21 CFR Part 820.
• Experience with risk management, PFMEA, design verification and design changes.
• Strong hands-on problem-solving capability.
• Excellent cross-functional communication and project management skills.
• Six Sigma / Lean Six Sigma experience is highly desirable, particularly DMAIC, structured root cause analysis and continuous improvement techniques.
• Engineering or relevant scientific degree preferred.

This Senior Quality Engineer opportunity would particularly suit someone who enjoys getting close to manufacturing problems rather than operating purely within documentation and compliance.

The successful Senior Quality Engineer will be able to identify issues, analyse data, establish true root causes and drive practical corrective actions through to implementation.

If you are a Senior Quality Engineer with strong medical device or regulated manufacturing experience, excellent problem-solving ability and a continuous improvement mindset, this is an excellent opportunity to take ownership of technically challenging quality projects.