Manager Quality Assurance, Integrated Systems

West

Waterford, Ireland
On-site
Quality management system (qms)
Customer facing quality issues
Supplier performance metrics
The primary responsibilities involve oversight of the Quality Management System (QMS), Customer Quality issues, and supplier performance metrics

Job Summary

  • The primary responsibilities involve oversight of the Quality Management System (QMS), Customer Quality issues, and supplier performance metrics.
  • Lead and drive internal teams to resolve Out of Spec (OOS) quality issues and be the main point of contact for customers on these issues.
  • Ensuring compliance to corporate, regulatory and customer quality standards will be at the forefront of the responsibilities.

Matching Summary

The primary responsibilities involve oversight of the Quality Management System (QMS), Customer Quality issues, and supplier performance metrics.

Skills & Requirements

Must-have

  • Quality Management System (QMS)
  • Customer facing quality issues
  • Supplier performance metrics
  • Out of Specification (OOS) investigations
  • ISO 15378 / ISO 13485 / 21 CFR Part 820 / EU GMP knowledge
  • Hosting regulatory audits

Nice-to-have

  • Lifelong learning and growth opportunities
  • Inclusive and collaborative culture
  • Benefit programs for health and wellness
  • Sustainability efforts

Key Requirements

  • BA/BSE in a technical or related field plus 5 years of experience
  • 5+ years work experience in Medical Device or Pharmaceutical Manufacturing
  • Accredited lead auditor against recognized quality standards
  • Experience in facilitation of quality risk management
  • Experience of hosting regulatory audits

Work Rights

Not specified

Tailored Resume

Cover Letter