Our client is a leading player in the Medical Device and Pharmaceutical sector, known for their commitment to innovation and quality. As part of their ongoing expansion and focus on New Product Introductions (NPI), they are investing in top talent to support their quality and validation functions. They are currently seeking an experienced NPI Quality Engineer to join their team in Munster, Ireland.

The Position

In this role, you will be instrumental in supporting NPI projects and process revalidation activities. Your focus will be on ensuring customer specifications are met, managing Process Risk Management, and overseeing the Validation Master Plan and related protocol reviews. You will provide technical and quality expertise to manage quality deliverables for selected NPI projects and daily validation tasks, ensuring timely resolution of internal and external quality issues.

Key Responsibilities Include:

• Reviewing and approving qualification and validation documentation related to instruments, equipment, facilities, utilities, and manufacturing processes across various validation phases (FAT, SAT, IQ, OQ, PQ).
• Ensuring validation documentation aligns with the Validation Master Plan (VMP) and customer requirements.
• Collaborating with third-party vendors to review and approve their protocols and reports.
• Supporting the development of Risk Management Plans for projects, covering quality, timelines, and commercial risks.
• Leading FMEA activities and ensuring that subject matter experts (SMEs) are trained and updated on relevant FMEAs.
• Facilitating the development of Risk Summary Reports (RSR) and supporting the completion of validation summary reports.
• Driving investigations into material and product issues, implementing root cause analysis, and ensuring corrective and preventive actions are in place.
• Leading the closeout of change control, deviations, and continuous quality improvements identified during projects.
• Preparing and presenting data at quality review meetings with customers.
• Supporting process output activities and setting up quality controls for smooth operational handover.
• Implementing best practices within the Quality Management System (QMS) as applicable.
• Playing a key role in internal and supplier audits, and preparing for third-party and customer audits.
• Tracking and trending quality data to drive continuous improvement initiatives.

The Person

• Bachelor's degree or higher in Engineering, Quality, Science, or a related discipline.
• Minimum of 3 years' post-graduate experience in a high-volume manufacturing environment, ideally in the Medical Device or Pharmaceutical sectors.
• Thorough knowledge of quality systems such as ISO 13485 / 21 CFR Part 820.
• Strong experience with validations in a Medical Device environment and an excellent understanding of plastic process manufacturing.
• Proficient in computer system validation and a solid understanding of statistical tools like SPC, with experience in Minitab being an advantage.
• Excellent communication skills, both oral and written, with experience in auditing preferred.
• Ability to prioritize and manage tasks effectively while ensuring compliance with safety and quality policies.

To discover more about this opportunity, apply now or contact Lewis Murray at HRM Search Partners via email at for a confidential discussion.