Associate Quality Engineer required for key role with growing medical devices scale up in Dublin or Galway or remote.  Reporting to the QA Manager, you will support on maintaining the Quality Management System and across all stages of product development. You should have a Degree in Engineering and some experience in a quality engineering role within a medical devices organisation or other highly regulated sector. 

Requirements: 

  • Bachelor’s Degree or higher-level degree in a relevant Engineering or Science field
  • 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

Key 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

  emer@emtechrecruitment.ie

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