Senior Quality Engineer ISO 13485

April 23, 2024
Reference key: ES12167
Deadline date:

Job Description

  • Negotiable
  • Permanent
  • Galway

Senior Quality Engineer with ISO 13485 and FDA QSR expertise market-leading Medical Devices company in Galway. Working with a collaborative team, you will Lead Quality Engineering support of the manufacturing process & drive process continuous improvements.


  • Process/manufacturing data analysis, trending and assisting yield reporting
  • Investigation root cause analysis of quality issues in manufacturing and managing quality related NC’s and CAPA’s
  • Establish analysis techniques and other quality control tools such as SPC, Cpk, Ppk
  • Lead the Materials Review Board (MRB) process
  • Address ongoing compliance
  • Establish inspection plans, frequencies and test methods for incoming material/parts
  • Appropriately train, develop and manage resources within the Quality Engineering support team to ensure objectives are communicated and delivered within agreed requirements
  • Ensure effective and timely closure of Quality system documentation (Audit Actions, NC’s, CAPA’s, Reject Report’s etc)
  • Support Quality Management in the development of key objectives and strategies to ensure continuous growth of personnel and quality systems improvements
  • Overall responsibility for GMP standards and compliance within manufacturing
  • Drive risk management activities in manufacturing (Process FMECA)
  • Manage process quality control system to ensure all manufactured product meets defined specifications prior to shipment
  • Maintain compliance with ISO and FDA Quality System regulations
  • Perform other assigned tasks and support all aspects of the Quality System as directed by the Manager


  • BE / BS Degree

  • 8+ years Quality Engineering experience or related role within the medical device industry

  • Thorough understanding of ISO 13485 and FDA QSR

  • Experience of leading and managing teams

  • Ability to work on own initiative

  • Strong team member with the ability to identify and drive implementation of innovative quality improvements

  • Ability to consistently meet deadlines

  • Demonstrate and actively promote high levels of professional quality engineering

  • Must have the ability to communicate effectively at all levels of the company

  • Ability to write clear, concise technical protocols and reports

  • Good administrative/organizational ability with high level of attention to detail

  • Ability to liaise with suppliers, customers and regulatory contacts in an informed professional manner