Quality Operations Manager

embecta

Dun Laoghaire, Ireland
Not specified; not specified; competitive pyy + be...
Onsite
Iso 9001/13485 compliance experience
Gmp standards adherence in production
Capa system management and documentation
This role leads the Quality Engineering Team to ensure alignment with ISO standards and regulatory requirements

Job Summary

  • This role leads the Quality Engineering Team to ensure alignment with ISO standards and regulatory requirements.
  • The position involves managing key quality system elements including non-conformance processes, incident reporting, and customer complaint analysis.
  • Candidates will oversee Quality Control activities and champion innovation while maintaining GMP standards in production.

Matching Summary

This role leads the Quality Engineering Team to ensure alignment with ISO standards and regulatory requirements.

Salary

Not specified; Not specified; Competitive pay and benefits included

Skills & Requirements

Must-have

  • ISO 9001/13485 compliance experience
  • GMP standards adherence in production
  • CAPA system management and documentation
  • FDA audit preparation and management
  • Non-conformance and incident reporting

Nice-to-have

  • Six Sigma Greenbelt Certification
  • Statistical Process Control knowledge
  • Process validation and sterilization expertise
  • Clean room environment familiarity
  • Inclusive growth-centered culture fit

Key Requirements

  • Third-level qualification in Engineering or Science
  • 5+ years in ISO 9001/13485 environments
  • At least 3 years of supervisory experience
  • Experience preparing technical documentation
  • Knowledge of FDA requirements

Work Rights

Not specified

Tailored Resume

Cover Letter