Quality Engineer

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 Griffinkevin.griffin@collinsmcnicholas.ie(021) 2427108