Quality Engineering Manager

embecta

Dun Laoghaire, Ireland
Onsite
Process validation activities review
Statistical process control spc application
Iso 9001 iso 13485 compliance management
This role provides operational and people leadership across Quality Engineering, Validation Engineering, and Quality Control functions

Job Summary

  • This role provides operational and people leadership across Quality Engineering, Validation Engineering, and Quality Control functions.
  • The position requires ensuring strong compliance with ISO, GMP, and regulatory requirements while supporting product quality and process improvement.
  • Candidates will act as a key quality contact for external customers and manage core quality systems including incident reporting and CAPAs.

Matching Summary

This role provides operational and people leadership across Quality Engineering, Validation Engineering, and Quality Control functions.

Skills & Requirements

Must-have

  • Process validation activities review
  • Statistical Process Control SPC application
  • ISO 9001 ISO 13485 compliance management
  • CAPA system and non-conformance management
  • GMP oversight across production activities

Nice-to-have

  • Six Sigma Green Belt certification
  • Sterilisation process knowledge
  • Cleanroom environment experience
  • FDA inspection support experience
  • Postgraduate qualification in Engineering

Key Requirements

  • Third-level qualification in Engineering or Science
  • Minimum 5 years in regulated ISO environment
  • At least 3 years supervisory or people management experience
  • Experience preparing technical documentation
  • Working knowledge of FDA requirements

Work Rights

Not specified

Tailored Resume

Cover Letter