QUALITY ENGINEER – MEDICAL DEVICES / PHARMA (3-MONTH CONTRACT WITH POSSIBLE EXTENSION)

Annacotty, Limerick | Immediate Start Required
Join a global leader in providing innovative medical technologies that improve the health and quality of people’s lives. This Limerick-based site specialises in OEM solutions for catheter and device manufacturing.
We are seeking a Quality Engineer for a 3-month contract to support FMEA and TMV updates. The successful candidate will play a critical role in ensuring compliance and driving improvements in manufacturing processes.

REQUIREMENTS

• Minimum 5 years’ experience in the Medical Devices or Pharmaceutical industry
• Bachelor’s degree in Engineering or related discipline
• Proven track record with pFMEA development and eQMS platforms
• Strong understanding of medical device regulatory standards (e.g., ISO 13485, FDA)
• Excellent problem-solving, documentation, and communication skills

• Lead the creation and updating of pFMEAs for catheter manufacturing processes
• Manage change control activities using an electronic QMS (Reliance preferred)
• Support Test Method Validations (TMV) in collaboration with cross-functional teams
• Ensure all documentation complies with regulatory and quality system requirements
• Work independently and hit the ground running in a fast-paced environment