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Quality Systems Specialist

  • Sector: Science & Pharma
  • Contact Email:
  • Job Ref: 21979

Our client, a reputable leader in the medical device industry, dedicated to innovation and unwavering commitment to safety and quality, is currently in search of a highly motivated and experienced Quality Systems Support professional to join their dynamic team.


  • Be the process expert for Quality Management Systems, ensuring a deep understanding of processes and products.

  • Lead and support the resolution of quality issues, overseeing root cause investigations and implementing effective corrective and preventive actions.

  • Assess changes to quality processes and determine if validation or re-validation is required.

  • Evaluate process capacity and set standard times in alignment with manufacturing plans.

  • Develop additional process capacity as necessary to meet production requirements.

  • Continuously evaluate and enhance process capability to optimize efficiency and quality.

  • Create and maintain comprehensive work instructions for manufacturing processes.

  • Collect and analyze quality data, focusing on Key Performance Indicators (KPIs) related to complaints, corrective actions, non-conformance reports, and continuous improvement.

  • Identify equipment and tooling needs and initiate replacement programs.

  • Ensure the maintenance of safe and compliant processes.

  • Conduct risk assessments and manage changes using the Management of Change (MOC) process.

  • Lead quality-based continuous improvement initiatives and maintain a structured idea hopper.

  • Maintain a regular reporting cadence on Quality Management projects.

  • Provide support for critical KPIs related to Safety, Quality, and Service.

  • Assist in regulatory affairs and international submissions.

  • Support programs related to material, component, and document obsolescence.

  • Contribute to manufacturing scale-up and New Product Introduction (NPI) integration efforts.


  • A minimum of a Level 8 degree, preferably in a physical/life science or engineering discipline.

  • Previous experience in the Medical Device industry with exposure to ISO 13485 and US FDA regulations is desirable.

  • Certification as an auditor to ISO 13485 would be highly advantageous.

  • Proficiency in Quality Management Systems, including Complaints, CAPA, NCR, and audit management.

  • Strong computer skills and experience with automated management systems.

  • Exceptional communication and interpersonal skills, capable of conveying technical information to diverse audiences.

  • Problem-solving skills and decision-making ability.

  • A keen attention to detail and the ability to maintain high standards despite deadlines.

For more information please contact Cathal Herron:

(090) 645 0660