Senior Quality Engineer: ISO 13485 & QMS Leader

Aurora Lifesciences; Yorkshire, Northern (VA, KY); Hybrid; USD 95,000 - 125,000; Full time

Job summary

Aurora Lifesciences is seeking a Senior Quality Engineer to own quality activities in a regulated manufacturing environment. You will support ISO 13485 QMS implementation, perform internal audits, drive CAPA and root-cause investigations, and collaborate with Production, Engineering and Supply Chain to improve quality across the business.

You will work on reviewing drawings and inspection reports, managing non-conformances, and analysing data to identify risks and opportunities for sustainable

Qualifications

• Strong practical knowledge of ISO 13485.
• Experience implementing or improving a Quality Management System.
• Experience planning, conducting and following up ISO 13485 internal audits.
• Experience supporting external, customer or regulatory audits.
• Proven experience managing CAPA, non-conformances and root cause investigations.
• Ability to use structured root cause tools (5 Whys, Fishbone).
• Experience leading quality or process improvement projects.
• Ability to interpret engineering drawings and inspection reports.

Responsibilities

• Own and drive ISO 13485 QMS implementation, development and maintenance.
• Lead and support internal audits and ensure corrective actions close.
• Support customer, supplier and regulatory audits.
• Lead quality improvement projects from problem to implementation.
• Investigate manufacturing and product issues and drive root cause resolution.
• Manage non-conformances, CAPA, deviations and concessions to closure.
• Review engineering drawings, specifications and inspection requirements.
• Oversee product and batch release activities and document traceability.
• Analyse quality data and KPIs to identify risks and improvement opportunities.

Skills

ISO 13485 knowledge

Root cause analysis

CAPA management

Quality data analysis

Auditing

Tools

CMM reports review

Dimensional inspection techniques

Job description

Aurora Lifesciences is seeking a Senior Quality Engineer to own quality activities in a regulated manufacturing environment. You will support ISO 13485 QMS implementation, perform internal audits, drive CAPA and root-cause investigations, and collaborate with Production, Engineering and Supply Chain to improve quality across the business.

You will work on reviewing drawings and inspection reports, managing non-conformances, and analysing data to identify risks and opportunities for sustainable