Senior Quality Manager (NPI) [Code: *******]
Croom Medical
Permanent full-time Limerick Office
Company Information and Introduction
Winner of the "Best Overall Business of the Year" in **** at the Limerick Chamber Awards.
Croom Medical is an industry leader utilising high-tech, high-growth, cutting-edge medical device manufacturing technology, working with the largest multinational Clients in the Medical Device arena, in particular Orthopaedic Implants.
Right now, is one of the most exciting times to join Croom Medical.
Our R&D team is developing implant technologies that have never been done before, including TALOSTM, our tantalum additive manufacturing platform, which won the Innovation in Engineering Award at the **** Irish Engineering Excellence Awards.
We have just broken ground on a new €18 million purpose-built manufacturing and R&D facility, and our team has tripled since ****.
Key Responsibilities and Duties
Drive and ensure quality compliance across all departments involved in New Product Introduction (NPI) processes.
Lead and develop direct reports within the regulatory and manufacturing quality teams, specifically supporting NPI projects.
Make certain that direct reports working on NPI initiatives receive necessary training and resources to execute their responsibilities effectively.
Design and implement robust quality systems and procedures tailored to NPI requirements, fully aligned with FDA regulations and ISO standards.
Champion quality representation throughout the lifecycle of new product launches and continuous improvements to existing products.
Address customer complaints and queries related to NPI products, ensuring prompt and thorough resolution.
Guarantee compliance with product development protocols and design controls during NPI activities.
Collaborate across departments to facilitate the execution of regulatory strategies for new product introductions.
Assess regulatory requirements for newly developed or modified products within the NPI scope.
Ensure complete adherence to applicable regulatory requirements for all NPI projects.
Track and audit quality-related activities specific to NPI operations onsite.
Initiate and manage non-conformance reports and CAPAs for quality issues arising from NPI, ensuring comprehensive investigations and corrective actions.
Key Skills and Competencies
Bachelor's degree (level 7 or higher) in quality or a related discipline.
Minimum of 3 years of proven people management experience.
5–10 years of experience in a regulated industry.
Strong knowledge of Quality Management Systems (QMS), FDA regulations, and ISO standards & NPI.
People Management Experience is essential.
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