We are looking for a Quality Director to join a Precision Engineering Facility based in Shannon, Clare on a permanent basis. Our client primarily contract manufactures and offers precision engineering solutions to top Medical Device companies in Ireland. As the Quality Director, you’ll play a pivotal role in driving excellence, innovation, and compliance across the organization along with providing visionary leadership for the Quality function.Your Key Responsibilities:Strategic LeadershipShape and execute a forward-thinking quality strategy aligned with the company’s long-term objectives.Be the face of quality, representing the company in all quality-related matters and regulatory engagements.Instil a culture of quality, accountability, and continuous improvement across all levels of the organization.Spearhead innovative quality initiatives that elevate operational and product excellence.Regulatory Compliance and Quality SystemsEnsure the Quality Management System (QMS) is world-class, compliant, and continuously evolving.Lead audits, ensuring flawless execution and compliance with FDA, QSR, ISO, and other global regulations.Analyze quality data, identify trends, and proactively address potential risks.Champion regulatory and customer requirements, embedding them into the organizational DNA.Operational ExcellenceProvide expert guidance on engineering, inspection, and measurement systems to enhance precision and efficiency.Oversee preventive maintenance and calibration processes, ensuring peak operational performance.Drive scrap reduction initiatives and lead root-cause problem-solving efforts.Approve and oversee CAPA actions to align with our robust quality systems.People LeadershipBuild, mentor, and inspire a high-performing quality team.Lead training initiatives to ensure the team is equipped to meet evolving quality standards.Collaborate across departments to foster innovation, alignment, and shared success.What We’re Looking For:Bachelor’s degree in a scientific or engineering discipline (advanced degree preferred).At least 15 years in quality management within the medical device or FDA-regulated industry, with 5+ years in senior leadership.Thorough understanding of QSR, ISO standards, and regulatory compliance. Lead Auditor certification is a plus.Proven track record in leading cross-functional teams, driving organizational change, and fostering high-performance cultures.For a confidential discussion and more information on the role, please contactAisling Lane.aisling.lane@collinsmcnicholas.ie(021) 4320675
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