Senior Quality Engineer

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.
The Senior Quality Engineer will be expected to take ownership of complex quality issues, lead root cause investigations and work cross-functionally to implement robust, sustainable corrective actions. Strong problem-solving capability is essential, with Six Sigma experience highly desirable, particularly candidates comfortable using structured problem-solving and continuous improvement methodologies.
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
As a Senior Quality Engineer, you should have:
 
* 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