Our client, a major multinational based in Galway city, is seeking a Quality Operations Engineering Manager to support operations as they continue to expand. This is an onsite role.
Overview:
We are looking for 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 drive quality systems, operational excellence, and ensure regulatory compliance within the organization, ensuring the safety, reliability, and quality of medical devices produced and delivered to patients.
Responsibilities:
* 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.
Key Accountabilities:
* 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.
Additional Responsibilities:
* 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.
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.