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Contact Info
James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Associate/Graduate Quality Engineer


Reference:JCAO2207 Location: Dublin
Qualification:DegreeExperience:0-1 Years
Job Type:PermanentSalary: Not Disclosed

Associate/Graduate Quality Engineer

Our client, a medical device start up is looking to expand their team to support its development and clinical activities with the recruitment of an Associate/Graduate Quality Engineer.
Reporting to the Quality Assurance Manager, the Associate/Graduate Engineer should have a hands-on approach to projects with a motivated attitude and strong work ethic. The candidate will support the QA Manager on maintaining the Quality Management System and across all stages of product development. An ability to work in a flexible and small entrepreneurial environment is essential.


Role/Responsibilities:

  • Support the QA Manager in development of quality plans, programs and procedures, through all aspects of the product development process.
  • Ensure all work is carried out in compliance with Quality, Regulatory and company policies and systems.
  • Ensure that performance and product quality conform to company, customer and regulatory requirements.
  • Assists in the review, analysis and reporting on quality discrepancies related to product design and manufacture.
  • Coordinates, implements, and maintains the company’s Document Control and Training System.
  • Supports labelling activities through change management interfacing with suppliers to meet quality standards and timelines.
  • Strictly follows established procedures and policies needed to meet the demands of document control in a regulated medical device company.
  • Assists in supporting external audits.
  • Maintains quality records per applicable SOPs.
  • Investigates and responds to corrective actions related to Document Control.
  • Responsible for coordinating document change notifications (DCN) approvals and release.
  • Supports incoming inspection activities.
  • Maintains records in clinical trial folders.

Skills/Experience:
  • Bachelor’s degree or higher-level degree in a relevant Engineering or Science field
  • 0-2 years’ experience in the medical device industry or other regulated industry
  • Strong verbal, written, organizational, time management and interpersonal skills
  • Strong computer skills, including working knowledge of MS Office and e-mail

For further information please contact James Cassidy [email protected] or call in confidence 086 0204322