Senior Quality Engineer with ISO 13485 & FDA experience required for permanent role with dynamic medical devices company designing life-saving medical devices in Galway.

You will manage both Product and Process Verification and Validation activities and lead Quality Engineering support on project activities. The role will require a high degree of flexibility to coordinate the variety of tasks as well as practical knowledge of current Project Management tools.

Hybrid working model.


  • BE/BS Degree
  • 5 years’ experience in a similar capacity in a regulated industry (i.e., FDA /ISO)
  • Minimum certification to Green Belt Lean Six Sigma (or recognized equivalent qualification)
  • Minimum of 3 years Supervisory / Management experience in a Medical Device /Pharmaceutical regulated industry
  • Thorough understanding of ISO 13485 and FDA QSR standards
  • Experience working in both an FDA and European regulatory environment is preferred with an in-depth knowledge of 21 CFR 820, CFR 11 and European regulations associated with the medical device industry
  • A thorough understanding of GMP/ISO and validation regulations
  • Experience of regulatory landscape with respect to FDA, CE Marking plus other regulatory territories while not mandatory is considered beneficial
  • Ability to work on own initiative
  • Strong team member with the ability to identify and drive implementation of innovative quality improvements
  • Ability to work within project teams, consistently meeting deadlines and ensuring that all actions are being addressed appropriately
  • Demonstrate and actively promote high levels of professional quality engineering
  • Must have the ability to communicate effectively at all levels of the company
  • Process Validation and Injection Moulding experience is desirable
  • Ability to liaise with suppliers, customers, and regulatory contacts in an informed professional manner
  • Good administrative/organizational ability with high level of attention to detail
  • Post-graduate qualification in Quality Assurance is preferable although not mandatory

Key Responsibilities:

  • Manage both Product and Process Verification and Validation activities as related to the specific scope of planned work associated with the asset / process in question
  • Lead Quality Engineering support on project activities i.e.: Design Improvements, Supplier Transfer’s, Cost Improvements, and New Product Introductions etc.
  • Manage activities within the project teams ensuring that project planning is completed correctly with full evaluation and engagement from the necessary resources
  • Lead investigation of quality issues should they arise during day-to-day production or within projects – work with project leaders, quality, materials, manufacturing, and suppliers to resolve issues
  • Liaise with the Supplier Quality group to ensure Supplier Approval Requirements are met
  • Ensuring conformance with current equipment, process and systems validation regulations
  • Determine process inputs and factors for variation where process capability is required
  • Partner with R&D and other cross functional teams to ensure the correct application of design controls, risk management and the investigation/correction of design failures/challenges
  • Provide timely and accurate reporting and management of escalations as appropriate on project activities
  • Establish analysis techniques and other quality control tools within project activities as well as utilization of these to solve specific quality problems
  • Overall responsibility for GMP standards and compliance within Project Teams
  • Maintain compliance with ISO and FDA and all other relevant ‘in country’ Quality System regulations
  • Utilization of recognized Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision
  • Utilize appropriate risk management to prevent unanticipated failure modes and help improves the capability of processes
  • Provide Statistic overview of all relevant activities to ensure that use of sampling plans and treatment of results adheres to best accepted statistical practice
  • Ensure that all health, safety, and environmental requirements are fulfilled
  • Support external audits, internal audits and any relevant Quality/Regulatory compliance related activities as deemed necessary

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