This leading medical devices organisation has been a long-time investor here in Ireland, with operations across multiple locations. Employing north of 10,000 employees globally, with over 50 sites and revenues in the billion plus range, they remain one of the leading providers of innovative, high-quality medical device solutions and services to the healthcare industry.

Since its introduction to Ireland, this business has continuously invested in its operations here, in addition to expanding across multiple sites. One of the organisation's primary manufacturing plants, based in Dublin, is currently undergoing significant investment and change, transforming its operations through strong leadership and continuous innovation, and demonstrating the importance of the site to the organisation's global manufacturing operations.

At present, a requirement exists for a Quality Engineer, supporting NPI projects and ongoing process revalidation, with key focus around customer specification, Process Risk Management, Validation Master Plan, and protocol reviews.

The Position

• In this role, the Quality Engineer will provide the company with the technical and quality resources to manage the quality deliverables on selected NPI projects and day to day validation activities, and will coordinate the necessary activities for ensuring the timely closure of internal/external quality issues on projects.
• The role will support development of the Risk Management Plan in conjunction with the Program Manager for the project covering quality, timeline, and commercial risks.
• The position will lead investigations into material/product issues encountered throughout the development/validation lifecycle to ensure thorough root cause, containment/corrective, and preventive action is implemented, and learnings are taken into Operations.
• This person will also review validation documentation (protocols & reports) as a quality review against the signed off VMP and customer requirements.
• This person will set-up of quality controls to ensure a smooth and effective handover to operations.

The Person

• Third level qualification, at a minimum degree level, in Engineering/Quality/Science.
• Ideally have a minimum of 4 years' post graduate experience working in a high-volume manufacturing environment, ideally in the Medical Device / Pharmaceutical sector.
• Working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 is essential.
• In-depth knowledge of validations in a manufacturing environment.
• Thorough understanding of statistics, SPC, and ideally the use of Minitab.
• Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 is preferred.

To learn more about this role apply online or contact Darragh McCarthy on + 353 879345234 for a confidential discussion.