Hands-on Quality Engineer: Root-Cause & Process Improvement

Aurora Life Sciences; Worrall; On-site; GBP 45,000 - 65,000; Full time

Job summary

Aurora Life Sciences is seeking a hands-on Quality Engineer who stays close to the product, the process and the people making it happen. In a regulated manufacturing environment, your work directly affects product performance, patient safety and customer satisfaction.

You’ll collaborate with Production, Engineering, Inspection and Supply Chain to keep manufacturing moving while upholding quality standards. You’ll lead root cause investigations, drive CAPA, review drawings and ensure traceability

Qualifications

• Experience in a regulated manufacturing environment.
• Ability to make informed decisions when issues arise.
• Strong root cause and CAPA skills.

Responsibilities

• Investigate production issues using structured root cause techniques.
• Lead root cause investigations into internal, supplier and customer non-conformances.
• Turn root cause findings into effective corrective and preventive actions that stop issues from coming back.
• Support inspection activities and review dimensional inspection results, including CMM reports.
• Review engineering drawings, specifications and inspection requirements.
• Complete product and batch release activities, ensuring documentation and traceability are accurate.
• Support incoming inspection and review supplier certification and documentation.
• Work directly with suppliers to resolve quality concerns and drive corrective actions.
• Support audits, maintain quality records and help improve procedures and processes.
• Analyse quality data, trends and KPIs to identify opportunities for improvement.

Skills

Quality Engineer experience

CAPA

Non-conformance management

Root cause analysis

ISO 13485

QMS

Data analysis

Microsoft Excel

Job description

Aurora Life Sciences is seeking a hands-on Quality Engineer who stays close to the product, the process and the people making it happen. In a regulated manufacturing environment, your work directly affects product performance, patient safety and customer satisfaction.

You’ll collaborate with Production, Engineering, Inspection and Supply Chain to keep manufacturing moving while upholding quality standards. You’ll lead root cause investigations, drive CAPA, review drawings and ensure traceability