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Associate Quality Engineer

Associate Quality Engineer

Job description

About Your New Employer

You will work for a medical device company based in Galway’s med-tech hub as an Associate Quality Engineer. You will report directly to the Quality and Regulatory Compliance Manager to support QMS, product development processes, and regulatory and compliance processes.

*Unfortunately, these positions are not suitable for candidates requiring Visa sponsorship*

About Your New Job   

As an Associate Quality Engineer, you will…

  • Maintain and support continuous improvement of the Quality Management System including system audits, CAPA, and Risk Management.
  • Performance, reporting, and follow-up through closure of internal quality system audits and external suppliers/subcontractors in compliance with applicable regulatory and QMS requirements.
  • Support, maintain and update the risk management system and risk management files.
  • Support, maintain and update the post market surveillance system and maintenance of PMS technical documentation.
  • Support biocompatibility testing and biological evaluation of medical devices.
  • Support the management review and design review processes.
  • Support Notified Body and US FDA inspections and compliance.
  • Support EU/US regulatory compliance by preparing compliance checklists and gap analyses for updated, including EU regulations, international standards, 21CFR820 requirements, guidance documents and communicate need for action.

What Skills You Need

  • Level 8 Degree in Engineering, Science, or a related discipline
  • Minimum of 2 years’ experience within the Medical Device or Pharmaceutical Industry
  • Experience and understanding of regulations related to medical devices e.g., ISO 13485, MDD/MDR, and applicable FDA Requirements.
  • Experience with technical writing

 What’s on Offer

  • Permanent Position
  • Competitive Salary and Benefits Package

What’s Next

Apply now by clicking the “Apply Now" button or call me, Lauryn Flanagan on +353 91 455306

Or if the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC and Contract jobs available.