Director, Global Quality - HealthTech jobs in United States
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Celestica · 3 days ago

Director, Global Quality - HealthTech

Celestica is a leader in design and manufacturing solutions, partnering with top companies across various industries including HealthTech. The Director, Global Quality for HealthTech will lead the global quality team, ensuring compliance with regulatory requirements and cultivating a quality-first culture across manufacturing facilities.

ElectronicsManufacturingProduct DesignSupply Chain Management
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H1B Sponsor Likelynote

Responsibilities

Develop 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 / 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 crossfunctional 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

Qualification

FDA certification processesQuality management systemsGlobal complianceISO standardsQuality auditsHealthTech industry experienceMicrosoft OfficeRelationship managementValidation principlesTesting proceduresCultural change for qualityInterpersonal skills

Required

Significant experience with FDA certification processes is required
Strong operational background
Customer-centric approach
Proven ability to deliver results
Accomplished and strong leader
Excellent communication and interpersonal skills
Proven history of driving operational excellence
Achieving business goals in a complex and dynamic environment
Develop and implement the global quality strategy in collaboration with regional and site leadership
Identify gaps and create short and long-term plans
Share best practices across HealthTech teams
Host quality forums for issue discussion, decision-making, and plan execution
Establish the HealthTech Quality Strategy (e.g., MDSAP / MDR)
Define annual quality objectives and metrics aligned with business priorities
Drive quality culture and performance improvements
Oversee the quality management system globally
Manage industry certifications, customer surveys, operational reviews, and system applications
Cultivate an 'audit-ready' culture
Direct the Global Regulatory Compliance Audit Program
Ensure internal audits are effective and findings are tracked to closure
Conduct Quality Management Reviews and training with manufacturing sites and executive management
Advise on risks and mitigation plans
Maintain an effective 8D reporting system for quality issues and resolutions
Manage talent within the Quality team, including hiring and training
Provide program management leadership for special projects and initiatives
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 (60%+)
10-12 years in quality management and related functions (Manufacturing Quality, Design Quality, Validation, Quality Assurance, Quality Systems)
Minimum 5 years conducting quality audits
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
Degree in Engineering or Sciences required

Preferred

RAC(US), CQA, ASQ, or ISO/RABSQA Auditor Certification is desirable

Benefits

Medical insurance
Dental insurance
Vision insurance
Short and long term disability
Life insurance
Voluntary benefits
401k plan with company match

Company

Celestica

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Celestica is a manufacturing firm that provides design, hardware platform, and supply chain solutions to a multitude of industries.

H1B Sponsorship

Celestica has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (3)
2023 (6)
2020 (3)

Funding

Current Stage
Public Company
Total Funding
$1.47B
2024-06-20Post Ipo Debt· $657.67M
2023-06-05Post Ipo Secondary· $148.8M
2021-09-30Post Ipo Debt· $660.4M

Leadership Team

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Robert Mionis
President and CEO
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Jonathan Baksh
Vice President Finance, Advanced Technology Solutions (ATS)
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Company data provided by crunchbase