This is a great opportunity for an experienced Quality Engineer to join a leading global healthcare and medical device organization based in Waterford. This role offers the chance to shape product and process quality, work with cutting-edge technologies, and drive continuous improvement in a dynamic, collaborative environment.
Key Responsibilities:
1. Provide technical support during new product introduction, ensuring compliance with FDA, QSR, and MDD requirements.
2. Apply quality engineering tools and techniques, including validation protocols (DQ, IQ, OQ, PQ), cGMP, PFMEA, and DMF generation.
3. Use scrap reduction methodologies and process capability analysis to deliver defect-free processes.
4. Support sterilization, automation, and equipment/software validation.
5. Operate in controlled manufacturing environments.
6. Participate in internal and external Quality Management System audits.
7. Support CAPA system and drive quality initiatives across departments.
8. Ensure compliance with GMP, company policies, and safety programs.
9. Apply root cause problem-solving in team settings.
10. Align customer specifications with operational capabilities.
11. Perform additional duties as needed.
Requirements:
12. Degree in Engineering or Science (Mechanical, Electronics, Chemistry).
13. 2–4 years' experience in Quality Engineering.
14. Competent in Quality Management Standards.
15. Skills & Attributes:
16. Strong leadership and team collaboration skills.
17. Excellent organization, communication, presentation, and computer skills.
18. Initiative-driven, solution-focused, with strong decision-making abilities.
19. Performance and results-oriented mindset.