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Responsibilities
SummarySenior Quality Manager - New Production Introduction (NPI) FocusDetailed DescriptionQuality Planning & Strategy: Lead the design and deployment of Quality Management Systems (QMS) processes and tools to ensure NPI objectives and customer requirements are met.DFx & Technical Readiness: Drive Design for Excellence (DFx) reviews and oversight on validation strategies (IQ,OQ,PQ) to ensure seamless product transitions from design to mass production.Launch Readiness: Manage launch readiness assessments, Monthly Operations Reviews, and Customer Satisfaction Surveys to ensure operational excellence at the HealthTech sites.Regulatory Oversight: Ensure site-wide conformance to international regulations and customer certifications (e.g., ISO 13485, ANSI/ESD).Performance Monitoring: Analyze data from customer scorecards, regulatory audits, and operational performance to identify gaps and communicate action plans to stakeholders.Global QMS process ownership: Develop and support key QMS processes to ensure regulatory compliance and mitigate operational risks.Process Deployment: Document and deploy global quality processes (Audit Compliance, Customer Feedback) in alignment with strategic corporate initiatives.Training & Capability Building: Educate sites on global procedures to build independent, high-functioning quality teams capable of maintaining long-term quality initiatives.Knowledge/Skills/CompetenciesQuality Frameworks: Expert-level knowledge of ISO 13485, 21 CFR 820 (QMSR) and ANSI/ISO/ESD standards.NPI Quality Planning: Deep proficiency ls, and system applications required to meet site-level and customer-specific quality objectives.Advanced Quality Tools: Mastery of core quality methodologies, including FMEA (Failure Mode and Effects Analysis), 8D Methodology, Change Control Board (CCB) protocols, and Manufacturing Quality Standards (MQS).Validation & DFx: Technical understanding of validation strategies (IQ/OQ/PQ) and Design for Excellence (DFx) to ensure seamless transitions from design to mass production.Performance Analytics: Ability to assess quality performance data to establish metrics, targets, and improvement strategies (e.g., Monthly Operations Reviews, Quality Excursion Reporting).Typical Experience15+ years of progressive experience h a proven track record in NPI, manufacturing scale-up, and global QMS deployment.Typical EducationBachelor’s Degree or higher lity Management or a related technical field.Industry certifications preferred (ASQ, Six Sigma, ISO13485 Lead Auditor, etc).Company OverviewCelestica (NYSE, TSX: CLS) enables the world’s best brands. Through our recognized customer-centric approach, we partner with leading companies munications, Enterprise, HealthTech, Industrial, Capital Equipment and Energy to deliver solutions for their most complex challenges. As a leader ufacturing, hardware platform and supply chaestica brings global expertise and insight at every stage of product development – from drawing board to full-scale production and after-market services for products from advanced medical devices, to highly engineered aviation systems, to next-generation hardware platform solutions for the Cloud. Headquartered h talented teams spanning 40+ locations in 13 countries across the Americas, Europe and Asia, we imagine, develop and deliver a better future with our customers.
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