Our client a major multinational based in Galway city are looking to hire a Quality Operations Engineering Manager to support operations as they continue to expand. This is an onsite role. Overview: We are seeking a highly skilled and experienced Quality Operations Engineering Manager to lead the quality engineering function in a high-tech, fast-paced medical device manufacturing environment. The ideal candidate will be responsible for driving quality systems, operational excellence, and ensuring regulatory compliance within the organization. This role is critical to ensuring the safety, reliability, and quality of medical devices that are produced and delivered to patients.
Responsibilities: Leadership & Management: Lead and mentor a team of Quality Engineers, ensuring optimal performance and professional growth.Collaborate with cross-functional teams (Operations, R&D, Regulatory, and Supply Chain) to drive quality improvement initiatives.Develop and implement strategic plans for quality operations, ensuring alignment with company goals.Ensure team adherence to company policies, procedures, and quality standards.Quality System Management: Oversee the execution and continuous improvement of the company's ISO 13485-compliant Quality Management System (QMS).Manage non-conformances, corrective and preventive actions (CAPA), risk management, and complaint handling processes.Ensure compliance with FDA 21 CFR Part 820, MDR, and other applicable regulatory requirements.Lead internal and external audits and act as the key point of contact for regulatory inspections.Manufacturing & Process Excellence: Drive quality improvement initiatives to optimize production efficiency and reduce product defects.Ensure that quality engineering methodologies (e.g., Six Sigma, Statistical Process Control) are integrated into manufacturing processes.Collaborate with Operations to ensure that all new products are launched with robust quality control systems.Facilitate the investigation and resolution of production issues through root cause analysis, developing effective solutions, and ensuring corrective actions are implemented.Supplier Quality Management: Collaborate with supply chain and procurement teams to ensure supplier quality performance meets the organization's standards.Develop and maintain strong relationships with critical suppliers to drive continuous improvement.Oversee supplier audits, inspections, and qualification processes.Regulatory Compliance: Stay updated on regulatory changes and ensure proactive compliance with emerging medical device standards and regulations.Lead initiatives that ensure the company's quality operations are ready for evolving global regulatory landscapes.Risk Management & Continuous Improvement:Manage risk assessment processes such as Failure Mode and Effect Analysis (FMEA) to minimize risks across operations.Drive a culture of continuous improvement using Lean and Six Sigma principles.Establish key quality metrics (KPIs) and drive performance improvements based on data-driven insights.Requirements: Bachelor's degree in Engineering, Quality Management, or a related field. A master's degree is an advantage.Minimum of 7-10 years of experience in Quality Engineering or Quality Management within the medical device or regulated industry.At least 3-5 years of experience in a leadership/management role.Extensive knowledge of ISO 13485, FDA 21 CFR Part 820, and Medical Device Regulation (MDR).Proven track record in leading successful audits (e.g., FDA, ISO) and managing post-audit corrective actions.Experience in process validation, statistical analysis, and risk management.For more information and a confidential discussion on the role please contactMichelle Mc Inerney. ****** 091 706 717
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