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:
- Provide technical support during new product introduction, ensuring compliance with FDA, QSR, and MDD requirements.
- Apply quality engineering tools and techniques, including validation protocols (DQ, IQ, OQ, PQ), cGMP, PFMEA, and DMF generation.
- Use scrap reduction methodologies and process capability analysis to deliver defect-free processes.
- Support sterilization, automation, and equipment/software validation.
- Operate in controlled manufacturing environments.
- Participate in internal and external Quality Management System audits.
- Support CAPA system and drive quality initiatives across departments.
- Ensure compliance with GMP, company policies, and safety programs.
- Apply root cause problem-solving in team settings.
- Align customer specifications with operational capabilities.
- Perform additional duties as needed.
Requirements:
- Degree in Engineering or Science (Mechanical, Electronics, Chemistry).
- 2–4 years’ experience in Quality Engineering.
- Competent in Quality Management Standards.
- Skills & Attributes:
- Strong leadership and team collaboration skills.
- Excellent organization, communication, presentation, and computer skills.
- Initiative-driven, solution-focused, with strong decision-making abilities.
- Performance and results-oriented mindset.
For a confidential discussion and more information on the role, please contact Kevin Griffin
kevin.griffin@collinsmcnicholas.ie
(021) 2427108