Quality Manager

Company and Role Overview

Our client operates a cutting-edge facility in County Offaly specializing in sterile barrier and performance packaging solutions for medical devices, diagnostics, and pharmaceutical drug delivery. The site handles critical packaging functions including design, prototyping, tooling, validation, laboratory services, and sealing equipment solutions tailored to comply with stringent healthcare regulations.

Key Responsibilities

• Lead and develop the quality team, ensuring alignment with company targets, standards, and budgetary constraints.
• Formulate and execute a comprehensive Quality Management strategy including resource allocation, system deployment, timelines, and financial planning, integrated with the organization's yearly business goals and long-term vision.
• Maintain, improve, and ensure compliance of the Quality Management System (QMS) per company policies and regulatory standards such as ISO 13485, FDA 21 CFR Part 820, GMP/GDP, and relevant customer codes.
• Manage and monitor the Quality Budget to minimize risks related to claims and control costs effectively.
• Serve as the site Management Representative, overseeing Management Review processes and ensuring timely closure of action items.
• Handle customer complaints through the QMS Complaint process, escalating urgent matters when necessary.
• Coordinate the corrective and preventive actions (CAPA) program employing suitable problem-solving methodologies.
• Develop and lead the internal audit program and facilitate third-party audits.
• Ensure adherence to Change Control protocols, collaboratively driving documented and prompt changes within the QMS.
• Generate and analyze QMS trends, metrics, and KPIs to provide insight for senior leadership regarding QMS performance and site priorities.
• Champion continuous improvement projects aimed at enhancing quality systems and compliance with corporate policies.
• Foster a quality-centric culture by engaging employees in quality awareness and improvement initiatives.
• Participate actively in project execution to improve quality system effectiveness.
• Communicate regularly with customers and suppliers regarding quality concerns impacting operations.
• Develop programs to boost operational efficiency and product quality within the facility.
• Act as the quality authority for disposition decisions on customer-related and material defects or issues.
• Design and deliver effective training sessions on quality assurance topics to both quality and non-quality staff.
• Implement corporate standardization efforts by supporting office-wide procedures.
• Ensure compliance with all Environmental, Health, and Safety (EHS) standards within the Quality team and broader site.

Required Qualifications and Experience

• Bachelor’s degree in Engineering, Science, or a related discipline; a Master's degree or equivalent additional studies is preferred.
• Between five and eight years of professional experience in quality roles within medical device or similarly regulated industries (including biotech, pharmaceutical, military, or aerospace manufacturing).
• At least three years of leadership experience managing Quality Management Systems and teams in manufacturing contexts.
• Proven proficiency in continuous improvement methodologies such as Six Sigma.
• Certification as a Quality Auditor (e.g., ASQ or ISO 13485) is preferred.
• Familiarity with regulatory frameworks including ISO 14971, ISO 13485, and FDA Quality System Regulations.