Senior Quality Engineer: Medical Devices, Hands-On Impact

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 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.