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James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Quality Engineer-Operations


Reference:JCA02106 Location: Galway
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Quality Engineer

Quality Engineer – Operations


Our client a high potential and fast growing medical device start up currently seeks a Quality Engineer to join their team. The Quality Engineer will work as part of the Quality and Regulatory Affairs teams and be responsible for tasks supporting the Operations function.


Role/Responsibilities:

  • Liaise with technical operations function to support the inspection and manufacturing activities at the OEM facility to ensure compliant product is consistently delivered.
  • Develop and implement inspection procedures for incoming components, in process assemblies and final product and manage and co-ordinate all inspection activities.
  • Manage and implement procedures for non-conforming product.
  • Develop and maintain PFMEA and provide direction in the development of validation protocols and reports.
  • Review DHR records and prepare product release documentation.
  • Prepare quality system metrics on a pre-determined basis to support management meetings and for management review.
  • Implement the CAPA system at ensuring that comprehensive root cause analysis is completed and that corrective and preventive actions are effectively implemented.
  • Support the supplier management programme ensuring that all sub-contractors, suppliers, and external parties meet and adhere to the requirements of the quality system.
  • Support the continuous improvement of quality system processes and the business generally.
  • Complete tasks as designated by your supervisor to support the needs of the business.

Skills/Experience:
  • Bachelor’s degree in Science or Engineering is a pre-requisite for this role.
  • A minimum of two years experience in a quality engineering or regulatory role ideally in a regulated environment. Medical device industry experience is an advantage.
  • A self-starter who can see and deliver the work required to advance the company goals with a minimal amount of direction.
  • Excellent written, interpersonal communication and presentation skills.
  • Holds him/herself and others accountable to meet commitments by following through, acting with a clear sense of ownership, and taking personal responsibility for decisions, actions and failures.


For further information contact James Cassidy [email protected] of call in confidence 0860204322