Quality System Engineer

3 weeks ago


Dublin, Dublin City, Ireland Cpl Full time

Quality Systems Engineer

This role supports the Quality Systems Manager and will include implementing & maintaining the Quality Management System in accordance with applicable standards and regulations.

Responsibilities:

  • Be a key driver of cGMP practices within Quality and Operations
  • Be the primary contact for other departments providing quality oversight to ensure compliance and promote quality improvements.
  • Ensure adherence to internal and external regulatory requirements
  • Be an active member of the internal audit team and support external audits at the site
  • Maintain effective implementation of site processes including Change Management, Internal Audits and CAPA
  • Prepare and present data to management on quality system performance
  • Drive thorough investigation & root cause analysis of CAPAs and Internal Audit findings. Support their timely resolution and ensure appropriate actions are taken to prevent recurrence
  • Support other Quality processes and implement improvement activities
  • Provide a quality review on a range of documentation including procedures, specifications, investigations, GMP records and other Quality Management System documentation as required

Educational Requirements:

  • A primary degree in a Science/Engineering discipline

Relevant Experience:

  • 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
  • Strong problem solving ability
  • Experienced in technical writing and review with good attention to detail
  • Proven ability of working on own initiative and in a cross-functional team environment
  • Excellent interpersonal and communication skills
  • Ability to prepare and present data effectively
  • Qualified Internal Auditor experience


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