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Quality Systems Engineer

  • TypeContract
  • SalaryNegotiable
  • LocationDublin
  • Published7 Mar 2023
  • Ref#BBBH12526
  • Apply now!

Role: Quality Systems Engineer

Client: Our client is a leading, multinational Medical Device company whose primary objective involves providing the best medical technology for medical research and clinical testing to occur in the world of health. Reporting to the Quality Systems Manager, the successful candidate will be responsible for the implementation & maintenance of the Quality Management System in accordance with applicable standards and regulations.

Location: South Dublin

Responsibilities:

  • Be a key driver of cGMP practices within Operations and Quality divisions.
  • Participate in internal and external audits.
  • Maintain effective implementation of site processes including Change Management, Internal Audits and CAPA.
  • Prepare and present data to management on quality system performance.
  • Conduct investigation & root cause analysis of CAPAs and Internal Audit findings.
  • Support process improvement activities.
  • Provide a quality review on a range of documentation including procedures, specifications, investigations, GMP records and other Quality Management System documentation.

Qualifications & Experience:

  • Third level qualification in a Science/Engineering or relevant discipline.
  • A minimum of 5 years work experience in the Medical Devices Pharmaceutical regulated environment working within an established Quality System
  • Proven experience leading CAPAs and Internal Audits
  • Experience in technical writing and review with good attention to detail

Lisa Jeyacheya

Senior Recruitment Consultant - Life Sciences

Lisa, based in our Dublin office is a Senior Recruitment Consultant and specialises in all things Quality Assurance and Regulatory Affairs. She holds a BSc in Nutraceuticals in Health and Nutrition from Technological University Dublin. Lisa has experience as a Medical Laboratory Aide and Medical Laboratory Technician. From here, Lisa moved into recruitment where she focuses on Quality and Regulatory based roles for the Pharma/Biopharma and Medical Device industries.

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I highly recommend working with Natalia both if you are looking for a new role or if you are looking for potential candidates. Natalia worked with me through the recruitment process and always gave brilliant advice. She is one of the best recruiters I’ve ever had the pleasure to work with. I was delighted to receive and accept an offer at the end of the process and can’t wait to get started in my new role. Thanks Natalia!

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