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Quality Systems Engineer

  • Sector: Engineering
  • Contact Email:
  • Job Ref: 20945

Our client, a world leading medical device manufacturer based in Galway who are designing, developing and manufacturing their range of neurovascular devices are looking to hire a Quality Systems Engineer (HYBRID) as they embark on the expansion of their team and facility

The purpose of this role is to support the Quality team in all aspects relating to our clients quality management system and processes. The role will involve liaising across the organisation to ensure internal system compliance and customer specifications are achieved. It will also demand the timely and effective closure of internal/external quality issues in a culture of compliance and continuous improvement.

Key Responsibilities

  • Implementing & maintaining the Company's Quality Management System in accordance with applicable standards and regulations

  • Be a key driver of cGMP practices within Quality, Operations, R&D, Supply Chain & Reg Affairs Depts

  • Act as a 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 NCR, CAPAs and Internal Audit findings. Support their timely resolution and ensure appropriate actions are taken to prevent recurrence.

  • 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 as required.

Skills, Qualifications & Experience

  • A minimum of 3 years work experience in the Medical Devices or Pharmaceutical regulated environment in a Quality Systems or Quality Assurance Role.

  • 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 is desirable

For more information on this role and a confidential discussion please contact Chris O Toole