Quality Manager

About Nelipak Healthcare Packaging

Nelipak Healthcare Packaging has spent 70 years building its position in the global healthcare packaging sector, growing from entrepreneurial beginnings into an established international business. The company operates 11 sites worldwide, with each location typically employing between 100 and 300 people. Its focus is on high-quality, bespoke packaging solutions that meet demanding industry needs and keep pace with the evolving healthcare packaging market.

Role Overview

The Quality Manager role is based in Clara, County Offaly and reports to the Operations Director, with a dotted reporting line to Nelipak’s Director of Quality Europe. This position is responsible for leading a team of quality professionals and ensuring that the plant’s Quality Management System and regulatory obligations are maintained at a high standard. The role also works closely with the Clara Site Leadership Team to help deliver performance targets and strategic goals.

Key Duties

• Lead, coach, and develop the Clara quality team in line with company policies, agreed targets, budgets, and people processes such as appraisals, discipline, training, and development.
• Create and execute quality strategy and related plans, covering resources, systems, timelines, and financial planning, so they align with the annual business plan and long-term direction of the organisation.
• Build, maintain, and improve the Clara QMS in line with internal procedures and regulatory expectations, including ISO 13485, FDA 21 CFR Part 820, GMP/GDP, and customer-specific codes of practice.
• Own the quality budget and help minimise exposure to claims and other quality-related costs and risks.
• Serve as the site Management Representative and oversee management review planning, delivery, and follow-up of action items.
• Ensure customer feedback is handled promptly through the complaint process, escalating major issues when needed.
• Drive effective CAPA activity using suitable problem-solving methods to achieve timely closure and lasting corrective action.
• Set up and maintain the internal audit programme and support external or third-party audits.
• Manage change control compliance, promoting timely and well-documented change control activity within the Clara QMS.
• Track and report quality trends, metrics, and KPIs so leadership has clear visibility of QMS performance and business priorities.
• Communicate product quality concerns clearly and in a timely way to support risk mitigation.
• Lead continuous improvement initiatives that strengthen the quality system and keep it aligned with corporate policies and procedures.
• Encourage a quality-first culture by building awareness and engagement across the workforce.

Requirements

• A bachelor’s degree in Engineering, Science, or another closely related discipline is essential; a master’s degree or equivalent additional study is preferred.
• Between 5 and 8 years of experience in quality engineering within a medical device or other regulated manufacturing setting such as biotech, pharma, or military/space.
• Practical experience with continuous improvement methods, including Six Sigma, is an advantage.
• Certified Quality Auditor qualification through ASQ or ISO 13485 is desirable.
• Strong computer literacy and advanced use of Microsoft Word, Excel, and PowerPoint are required.
• Working knowledge of regulations and standards such as ISO 14971, ISO 13485, and FDA Quality System Regulations.

Benefits

• Competitive annual salary.
• Paid annual leave and sick leave.
• Retirement plan options.
• Employee Assistance Programme (EAP).
• Wellness programmes.
• Employee recognition initiatives.
• Free on-site parking.
• Death in service cover.
• Learning and development opportunities.
• Cycle to Work Scheme.
• Bonus plan.
• E-learning and development opportunities.

Additional Information

Nelipak describes itself as an equal opportunity and inclusive employer. Applications are treated confidentially, and the company states that it will not contact a candidate’s current employer during the hiring process. Because the position is urgent, applicants must already be eligible to work in the job location to be considered. The listed responsibilities are not exhaustive, and the role holder may reasonably be asked to carry out other duties that fall within the scope of the position.

Closing Date

The application deadline is Thursday, 2 July 2026.