Arcadis are recruiting a Quality Engineering Manager - NPI for a leading Medical Device company in Dublin on an 18 month, hourly-rate contract.
Introduction to the Role This is a key leadership role responsible for driving critical projects to support the successful introduction of new products.
The role involves leading a high-performing team of Quality Engineers (7+ people), overseeing validation activities, and collaborating across multiple internal functions and external partners to ensure delivery of world-class quality standards.
Key Responsibilities Leadership & People Management Lead, mentor, and develop the Quality Engineering team through effective daily management, coaching, performance reviews, and clear delegation of responsibilities.
New Product Introduction (NPI) Oversee and deliver all Quality Engineering aspects of NPI projects, ensuring timelines, validation standards, and regulatory expectations are met.
Quality System Ownership Maintain and continuously improve quality systems in line with ISO 9001 and ISO 13485 standards, including areas such as non-conformance management, incident reporting, and customer complaint analysis.
Regulatory Compliance Ensure all quality activities comply with companies internal procedures and external regulatory standards (FDA, ISO, etc.) CAPA Management Lead and ensure timely and effective execution of Corrective and Preventive Actions (CAPAs) aligned with regulatory and quality expectations.
GMP & Manufacturing Support Ensure Good Manufacturing Practice (GMP) compliance in Production and Quality Engineering operations, supporting site manufacturing goals.
Customer & Cross-functional Engagement Act as a key quality contact for external customers and internal stakeholders across Operations, R&D, Regulatory Affairs, and other functions.
Process Improvement Champion continuous improvement initiatives using operational excellence / continuous improvement methodologies to enhance product quality, process robustness, and efficiency.
Documentation & Validation Oversee the preparation, review, and approval of high-quality technical documentation to support validation studies and regulatory submissions.
Qualifications & Experience Minimum 5 years experience in a regulated ISO environment, preferably within the medical device or pharmaceutical sector At least 2 years of experience in a supervisory or leadership capacity Demonstrated experience in leading validation and quality system improvement projects Interested parties should submit a copy of their CV through the link below or contact Fergal Walshe via Linked In for more information Skills: Quality Engineering CAPA CAPAs NPI QA Medical Device