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 Leadership
* Shape 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 Systems
* Ensure 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 Excellence
* Provide 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 Leadership
* Build, 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 contact Aisling Lane.
aisling.lane@collinsmcnicholas.ie
(021) 4320675
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