Quality Engineering Manager

About the Role

This position leads quality engineering activities at a manufacturing site, with responsibility for keeping the quality system running smoothly and ensuring that in-process and finished product checks are carried out effectively. The role also covers process audits, final release records, failure investigations, and compliance support for valve assembly manufacturing. A strong focus is placed on building a quality-first culture while meeting global regulatory expectations.

What You’ll Do

• Lead supervisors and/or a quality assurance team within the function, across one or more production lines or projects, while building a strong development plan that supports department growth goals and continuous improvement.
• Own quality assurance project work such as CAPA, ensuring deliverables are completed on time, within scope, and to the required quality standard. Identify risks, create mitigation plans, evaluate alternatives, resolve issues, and track actions with cross-functional partners.
• Work with teams across the business to oversee inspection of in-process and finished goods, assemblies, and components, making sure inspection activities are correctly implemented.
• Work through solutions with Manufacturing Operations, Supply Chain, Engineering, and other groups to support continuous improvement.
• Lead project plans, timelines, scope, and objectives using engineering approaches such as Six Sigma and Lean, including design/re-design support for new products and processes.
• Oversee team or cross-functional project activity, including some budget responsibility, and continue to strengthen the talent development plan for the department.
• Provide technical direction to cross-functional and departmental teams and offer design recommendations for components or products of moderate complexity.
• Drive the CAPA program, including training, approvals, and checks on system effectiveness.

What You Need

• A bachelor’s degree in Science or Engineering, along with relevant prior experience.
• Experience managing internal audit programs and external regulatory inspections/audits for Class II/III medical devices, or comparable experience aligned to company criteria.
• A proven record of people management, or equivalent experience under company criteria.
• Background working in a regulated industry, or equivalent experience under company criteria.

Additional Requirements

• Strong project management leadership ability.
• Advanced working knowledge of Microsoft Office, including Excel, and related quality systems.
• Excellent documentation, communication, interpersonal, negotiation, and relationship management skills.
• Deep understanding of quality procedures and the ability to handle issues that affect areas beyond the immediate team.
• Strong knowledge of quality processes, systems, and financial considerations related to quality.
• Good command of applicable quality regulations, including cGMP compliance.
• Ability to manage a team, coach and give feedback, and handle employee actions, including hiring and termination responsibilities in partnership with HR.
• Capability to build and use metrics that show the business value of quality activities.
• Very strong attention to detail.
• Ability to work professionally with all levels of the organization and escalate issues appropriately when needed.
• Comfort working in a fast-moving, changing environment.
• Knowledge of Lean Manufacturing and Six Sigma concepts.
• Regular interaction with production supervisors, customers, and peer managers, often across functional areas or business units, and frequently leading cooperative project efforts.
• Ability to attend and present in meetings with internal and external stakeholders.
• Capability to resolve operational and scheduling challenges.
• Commitment to high-quality client service and responsiveness to client needs.
• Ability to build peer, cross-functional, and cross-business relationships to share best practices and improve team effectiveness.
• Ability to develop relationships and use them to influence change.
• Comfort gathering input from team members at all organizational levels.
• Willingness to follow company rules and requirements, including pandemic protocols and Environmental Health & Safety standards, while taking proper steps to protect people and the environment and prevent pollution within the area of responsibility.
• Strong problem-solving, organizational, analytical, and critical thinking skills, with sound judgment in decision-making.
• Expert knowledge of engineering procedures related to quality issues and associated disciplines.
• Expert understanding of quality engineering processes and systems.
• Strong knowledge of domestic and international regulatory requirements, including FDA, GMPs, and ISO/EN standards.
• Expert knowledge of design of experiments, process capability studies, failure mode and effects analysis, statistical process control, industrial statistics, and Lean Manufacturing.
• Financial awareness as it relates to the business and quality engineering.

Workplace

This is a full-time onsite role based in Limerick, County Limerick, Ireland.

About the Company

The employer’s manufacturing teams support sewing, assembly, delivery, and distribution work that helps create devices and technologies intended to improve patient outcomes worldwide.