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Senior Quality Engineer

  • Sector: Engineering
  • Contact Email:
  • Job Ref: 22823

Our client a major multinational based here in Galway are looking to hire a Senior Quality Engineer for aninitial 12 contract to support an exciting new project.

Working Model: Hybrid or Remote options.

The Role:

As the Senior Quality Engineer you will work within Quality team and you will be responsible for implementing, maintaining the quality management system, ensuring effective compliance in accordance with regulatory requirements.  


  • Carries out duties in compliance with established business policies and procedures.

  • Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.

  • Remains current with regulations and standards.

  • Support the continuous improvement of quality system processes.

  • Assist in the preparation and maintenance of records associated with the management review process including metrics.

  • Apply problem-solving skills in order to deal creatively with moderately complex situations, work that typically requires processing and interpreting, more complex, less clearly-defined issues. Identifies problems and possible solutions and takes appropriate action to resolve. 

  • Drive compliance cross functionally in alignment with the Business Unit objective for standardization and collaboration. 

  • Owning and completing CAPAs in Agile PLM.

  • Authoring and maintaining procedures, work instructions, forms, and templates to ensure that processes are compliant with Corporate policies, external quality standards/regulatory requirements and customer (Entity) requirements.

  • Support other QMS activities as required.

  • Communicate confidently and effectively with all levels of management, peers and key stakeholders, including timely escalation of quality issues.

  • Execute and provide on-time completion of Quality Assurance deliverables.

  • Provide support and subject matter expertise during audits and inspections.

  • Lead and/or contribute to continuous improvement initiatives and projects.

  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.


  • Bachelor’s Degree / master’s degree in a science or technical discipline

  • 5+ years’ experience in a Quality Assurance/Systems engineer role within a relevant regulated industry plus demonstrated competence.

  • Detailed knowledge of FDA QSR (21 CFR Part 820), GMP, MDSAP, IVDR and ISO 13485.

  • Solid communication and interpersonal skills.

  • Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.


  • Prior medical device experience.

  • Six Sigma root cause analysis/problem solving training and experience.

  • Significant CAPA management experience and previous experience in mentoring CAPA owners.

For more information and a confidential discussion on the role please contact Michelle Mc Inerney.

091 706717