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
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