Quality Assurance Manager

My client is an award-winning, high-growth medical device manufacturer and a recognised leader in advanced, high-tech production solutions. The company partners with leading multinational organizations in the medical device sector, with particular expertise in orthopedic implants.

The Quality Manager NPI will drive and ensure quality compliance across all departments involved in New Product Introduction activities. This role is critical in leading regulatory and manufacturing quality functions to support successful product launches in a highly regulated environment.

• Drive quality compliance across all NPI-related functions.
• Lead and develop direct reports within regulatory and manufacturing quality teams supporting NPI projects.
• Ensure team members working on NPI initiatives receive appropriate training and resources.
• Design and implement robust quality systems and procedures aligned with FDA regulations and ISO standards.
• Act as the quality representative throughout the lifecycle of new product launches and continuous product improvements.
• Manage customer complaints and queries relating to NPI products, ensuring thorough and timely resolution.
• Ensure compliance with product development protocols and design controls during NPI activities.
• Collaborate cross-functionally to support regulatory strategies for new product introductions.
• Assess regulatory requirements for new or modified products within the NPI scope.
• Ensure full adherence to all applicable regulatory requirements across NPI projects.
• Track, monitor, and audit NPI-related quality activities onsite.
• Initiate and manage non-conformance reports (NCRs) and CAPAs arising from NPI, ensuring detailed investigations and effective corrective actions.

• Bachelor’s degree in Quality or a related discipline.
• Minimum 3 years’ proven people management experience.
• 5–10 years’ experience within a regulated industry
• Strong working knowledge of Quality Management Systems (QMS), FDA regulations, ISO standards, and NPI processes.
• Demonstrated leadership capability with strong communication and organizational skills.
• People management experience is essential. xcfaprz

If you are an experienced Quality professional with strong NPI and leadership experience seeking a strategic role in a growing, innovation-driven organization, this opportunity offers excellent career progression and the chance to make a real impact.