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 embecta’s 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 9001/13485 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 LinkedIn for more informatio
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