Global Quality Manager

Senior Manager, Global QualityWe are seeking an experienced Senior Manager of Global Quality to lead and develop a world-class HealthTech quality organisation. This role is responsible for driving a quality-first culture across multiple manufacturing sites worldwide while ensuring adherence to regulatory standards and delivering high-quality outcomes for customers and partners.About the Role The ideal candidate is a strategic leader with a strong operational mindset and a customer-oriented approach. They will excel at building relationships across regions, guiding cross-functional teams, and driving continuous improvement. This position requires a proven track record of managing complex quality systems in a regulated environment, including significant experience with FDA certification and compliance activities.Key Responsibilities:Develop and execute a global quality strategy aligned with business objectives.Collaborate with regional and site leadership to identify gaps and implement action plans.Lead global quality forums to share best practices, resolve issues, and enable decision-making.Establish and maintain quality management systems and industry certifications (e.g., MDSAP, EU MDR).Define annual quality objectives and key performance metrics to foster a culture of excellence.Promote an “audit-ready” environment and oversee global regulatory audit programs.Conduct Quality Management Reviews with executive and site leadership teams.Lead the 8D corrective action process and ensure effective closure of quality issues.Recruit, develop, and mentor quality team talent across global locations.Provide leadership for special projects and cross-functional quality initiatives.Required Skills and Experience:10–12 years of experience in quality management functions such as Quality Assurance, Quality Systems, Validation, Design Quality, or Manufacturing Quality.Minimum 5 years of experience conducting internal or external audits.Strong understanding of FDA, ISO, RAC, and CQA standards and regulatory requirements.Experience managing global, multi-site teams.Proven ability to drive cultural transformation and embed quality principles.Proficiency in data analysis and reporting (Microsoft Office suite).Strong relationship-building, communication, and influencing skills.Willingness to travel internationally (approximately 15%+).Education & Certifications:Bachelor’s degree in Engineering or a related Science discipline required.Preferred certifications: RAC (US), CQA, ASQ, or ISO/RABSQA Auditor.