Health Tech Senior Manager, Global Quality
4 weeks ago
OverviewThe Senior Manager, Global Quality for HealthTech is responsible for managing the global HealthTech quality team in Celestica Galway to establish and maintain a quality-first culture across worldwide manufacturing facilities.This involves managing a large global organization, collaborating with customers, suppliers, and partners, and ensuring compliance with regulatory requirements (FDA, ISO, ASQ, RAC).Significant experience with FDA certification processes is required.ResponsibilitiesDevelop and implement the global quality strategy in collaboration with regional and site leadership, identifying gaps and creating short and long-term plans.Share best practices across HealthTech teams and host quality forums for issue discussion, decision-making, and plan execution.Establish the HealthTech Quality Strategy (e.g., MDSAP / EU MDR).Define annual quality objectives and metrics aligned with business priorities, driving quality culture and performance improvements.Oversee the quality management system globally, including industry certifications, customer surveys, operational reviews, and system applications.Cultivate an audit-ready culture and direct the Global Regulatory Compliance Audit Program, ensuring internal audits are effective and findings are tracked to closure.Conduct Quality Management Reviews and training with manufacturing sites and executive management, advising on risks and mitigation plans.Maintain an effective 8D reporting system for quality issues and resolutions, involving cross-functional staff.Manage talent within the Quality team, including hiring and training.Provide program management leadership for special projects and initiatives and guide quality communities and internal teams.Strong relationship management and interpersonal skills.Proficiency in Microsoft Office for data analysis and reporting.Understanding of validation principles and testing procedures.Knowledge of FDA, ISO, RAC, and CQA regulations and standards.Willingness to travel internationally (15%+).Experience with FDA and regulatory inspections.In-depth knowledge of quality management systems and global compliance.Experience in the HealthTech industry.Global and multi-site leadership experience.Experience in driving cultural change for quality awareness.Typical Experience***** years in quality management and related functions (Manufacturing Quality, Design Quality, Validation, Quality Assurance, Quality Systems).Minimum 5 years conducting quality audits.Typical EducationEducation: Degree in Engineering or Sciences required.RAC(US), CQA, ASQ, or ISO/RABSQA Auditor Certification is desirable.NotesThis job description is not intended to be an exhaustive list of all duties and responsibilities of the position.Employees are held accountable for all duties of the job.Job duties and the % of time identified for any function are subject to change at any time.LocationGalway, County Galway, Ireland#J-*****-Ljbffr
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