Medical Device Quality Assurance Specialist

4 days ago


Portlaoise, Laois, Ireland Cpl Healthcare Full time

About the Role:

Cpl Healthcare is seeking a highly skilled Quality Engineer to join their team in North Kildare. As a key member of the Quality Operations team, you will be responsible for supporting the ongoing development of quality engineering functions for the plant.

Key Responsibilities:

  • Support the identification and introduction of new world-class techniques and technologies
  • Liaise with Automated Production & Engineering to ensure goals, targets, and objectives are met
  • Represent the company on quality issues and provide expertise and support
  • Investigate productivity issues, product, plant, or material deviations, and liaise directly with external suppliers and stakeholders
  • Support production line areas for quality and material issues
  • Closely work with partners across the value chain for process, quality, and cost improvements projects
  • Contribute to lean concepts and introduce them to enable identification of opportunities for improvements
  • Review and approve deviations, change controls, SOPs, out-of-specification compliances, lab or testing investigations
  • Lead internal audits and reviews of manufacturing operations and quality systems to ensure compliance with GMP and other regulations

Requirements:

  • BSc in Engineering, Quality Systems Management, or related field of expertise
  • Minimum 3 years' experience in medical device, food, and beverage production, or pharmaceutical manufacturing product development, quality control, and/or cGMP compliance
  • Experience with ISO13485 is advantageous


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