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Quality Systems Engineer Hybrid

  • Location: County Westmeath
  • Job Type:Permanent
  • Sector: Science & Pharma
  • Contact Email:
  • Job Ref: 22717

We are delighted to introduce a senior quality opportunity to join our esteemed client in the medical device industry as a Quality System Engineer. Our client is a leader in the field, dedicated to producing high-quality medical devices and advancing healthcare. If you have a passion for quality assurance, a proven track record of excellence, and a desire to drive innovation, we invite you to explore this role and become a vital part of our growing team.Our client is a well-established and reputable player in the medical device industry. With a commitment to improving healthcare through cutting-edge technology, they have consistently delivered high-quality, life-saving products to patients around the world. You will also get the opportunity to see other functions of the organisation such as Sterile Manufacturing, medical device equipment from a product knowledge perspective.

This position will be a senior Quality position within the team. As the more experienced Quality System Engineer, you will play a pivotal role in ensuring the quality and safety of our medical devices.


  • Representing Quality function in Site Management meetings as required.

  • Acting as a delegate for the Quality Lead.

  • Lead investigations and providing technical guidance to peers in relation to CAPAs and NC and to address compliance issues and providing guidance to engineering. 

  • Leading and implementing significant process improvements, projects and cost saving initiatives using data & quality tools to drive quality decisions. Initiating project plans, identifying resource allocations, performing and guiding technical activities such as risk documentation, procedural updates, test methods, process / software validation that have major importance to the business.

  • Initiating, reviewing, approving, and providing guidance on change controls and change control process.

  • Performing, analysing and interpreting statistical data using a detailed understanding of statistical tools and methods.

  • Leading investigations and providing technical guidance to peers in relation to CAPAs and NC and to address compliance issues and providing guidance to engineering. Leading the implementation of robust solutions. 

  • Ensuring QMS is implemented and adhered to by completing independent assessment of QMS documentation as required. Independently assess and provide guidance to Quality and Engineering disciplines.

  • Provide periodic training for company personnel on the company’s Quality System processes and procedures.

  • Performing and leading Internal and Supplier Audits.

  • Facilitating and participating in external regulatory body audits, e.g. ISO and FDA

  • Implementing Key Performance Indicators within the Quality Assurance area to align with site and global quality objectives.

  • Complete data analysis for Management Review.

  • Coordinate collection of data for PMS.

  • Actively lead QMS Process Improvement Projects

  • Complying with all relevant training required and adhere to relevant associated documentation.

  • Abiding to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.

  • Following strict adherence to the requirements of CGMP.

  • Ensuring compliance to quality systems and all applicable regulations/standards, and internal procedures.


  • Degree in Engineering or Science related field (minimum level 8)

  • Lead Auditor or Internal Auditor certification an advantage.

  • 5 years’ experience working in a regulated environments, specifically medical device

  • Strong knowledge of statistical tools and techniques

  • Strong knowledge of FMEA’s (Failure Mode and Effects Analysis) and root cause analysis tools.

  • Strong knowledge of problem solving techniques.

  • Ability to effectively communicate highly technical information, both verbally and in writing, to both non-technical and technical associates.

  • Knowledge of the Quality System Regulation and associated regulations and standards.

  • Attention to detail and accuracy is essential.

Some Benefits on offer:

  • Hybrid working flexibility on days

  • Company Pension Contribution up to 10% company contribution

  • Life Assurance – 4x salary

  • Family Healthcare

  • Long Term Disability benefit

  • 25 days holiday increasing with service


If you are interested in learning more about this fantastic opportunity, please contact Gillian Nicholson.

(090) 645 0665