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Quality Manager (NPI)
Industry specialist
Owen Clancy
Recruitment Consultant
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€65000 - €75000 per annum
Permanent
Quality Manager – New Product Introduction (NPI)
Role Overview
The Quality Manager – NPI is responsible for driving quality excellence across all departments involved in New Product Introduction processes. This role ensures full regulatory compliance, robust quality system implementation, and strong cross-functional collaboration to support successful product launches in a regulated environment.
Key Responsibilities
Leadership & Team Developme
Quality Systems & Complianc
Regulatory & Cross-Functional Collaboratio
Issue Resolution & Continuous Improvemen
Required Experience & Qualification
For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose
Role Overview
The Quality Manager – NPI is responsible for driving quality excellence across all departments involved in New Product Introduction processes. This role ensures full regulatory compliance, robust quality system implementation, and strong cross-functional collaboration to support successful product launches in a regulated environment.
Key Responsibilities
Leadership & Team Developme
- Lead and develop direct reports within the Regulatory and Manufacturing Quality teams supporting NPI projects.
- Ensure team members receive appropriate training, resources, and mentorship to perform effectively.
- Foster a culture of quality, accountability, and continuous improvement.
Quality Systems & Complianc
- Design, implement, and maintain robust quality systems and procedures tailored to NPI requirements.
- Ensure full alignment with FDA regulations, ISO standards, and internal QMS requirements.
- Guarantee compliance with product development protocols and design controls during NPI activities.
- Track, monitor, and audit quality-related NPI activities onsite.
Regulatory & Cross-Functional Collaboratio
- Collaborate cross-functionally to support regulatory strategies for new product introductions.
- Assess regulatory requirements for newly developed or modified products within NPI scope.
- Ensure adherence to all applicable regulatory requirements for NPI projects.
Issue Resolution & Continuous Improvemen
- Champion quality representation throughout the lifecycle of new product launches and improvements to existing products.
- Address customer complaints and queries related to NPI products, ensuring timely and thorough resolution.
- Initiate and manage non-conformance reports (NCRs) and CAPAs arising from NPI activities.
- Ensure comprehensive investigations and implementation of effective corrective and preventive actions.
Required Experience & Qualification
- Bachelor’s degree (Level 7 or higher) in Quality, Engineering, Science, or a related discipline.
- Minimum of 3 years’ proven people management experience.
- 5–10 years’ experience in a regulated industry (e.g., medical devices, pharmaceuticals, life sciences).
- Strong working knowledge of Quality Management Systems (QMS), FDA regulations, ISO standards, and NPI processes.
- Demonstrated leadership and people management capability (essential).
- Responsibilities may evolve based on business needs.
- The Quality Department Manager will communicate any required changes to scope.
- The employee must adhere to all company procedures and GMP requirements at Croom Medical.
For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose
