QuidelOrtho · 1 day ago
Director of Global Supply Network Excellence
US - New York
Full-time
Onsite
Director/Executive
$155K/yr - $249K/yr
12+ years expQuidelOrtho is a world-leading in vitro diagnostics company formed by the unification of Quidel Corporation and Ortho Clinical Diagnostics. They are seeking a Director of Global Supply Network Excellence to lead a team of Quality professionals, ensuring the implementation and continuous improvement of Quality systems and compliance across the supply network.
Medical Device
Responsibilities
Lead, develop, and inspire a team of Quality professionals to achieve organizational and individual performance objectives
Establish clear priorities, assign responsibilities, and ensure effective resource allocation to meet business and compliance needs
Provide technical, regulatory, and operational leadership to ensure Quality systems comply with ISO 13485, FDA 21 CFR 820, IVDR, and other applicable requirements
Management Responsibility as required by ISO13485/9001 and ensuring specific economic operator roles are fulfilled – for example, importer / distributor / Authorized Representative responsibilities
Drive harmonization and standardization of Quality processes, procedures, and tools across sites and functions to strengthen compliance and efficiency
Partner with Manufacturing, R&D, Regulatory Affairs, Supply Chain, and other stakeholders to integrate Quality and Compliance principles throughout the product lifecycle
Promote a culture of continuous improvement by identifying opportunities for simplification, process excellence, and digital enablement within the Quality Management System (QMS)
Ensure the team maintains a state of inspection readiness and supports successful engagement with regulatory agencies, notified bodies, and internal audits
Monitor Quality performance using metrics and data analytics to identify risks, drive root cause analysis, and implement sustainable improvements
Coach and mentor emerging Quality leaders and technical experts to build organizational capability and ensure robust succession planning
Communicate Quality and Compliance strategy, progress, and risk mitigation plans to senior leadership and cross-functional stakeholders
Manage departmental budget and resources effectively, identifying opportunities to drive cost efficiencies while maintaining compliance and quality standards
Model QuidelOrtho’s leadership principles by demonstrating collaboration, accountability, inclusion, and service mindset in all interactions
Person Responsible for Regulatory Compliance (PRRC per EU IVDR (2017/746) on behalf of the wholly-owned legal manufacturers of QuidelOrtho Corporation as defined in the Delegation of Authority (DMS-POL80064)
Article 15(3)(a): Responsible for ensuring that the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released
Execution of Importer and distributor responsibilities, specially making sure that the devices placed on the market bear the CE marking, are accompanied by the required information and labelled in accordance with the Regulation, and storage and transport conditions are in line with specifications
Perform other work-related duties as assigned
Qualification
Required
Bachelor's degree in Life Sciences, Engineering, or a related technical discipline required
12+ years' experience in Medical Device quality system management
Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR
Experience/knowledge of Supplier Quality Management Processes, auditing, Change Management, Root Cause Analyses, Corrective/Preventive Actions
Experience/knowledge with distribution processes, logistics and supply chain operations
Proven ability to lead and develop high-performing teams and build future technical and people leaders
Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations
Excellent collaboration, influence, and communication skills across functional and organizational boundaries
Strong analytical and problem-solving skills, with experience using data to drive decision-making and improvement
Experience leading in a matrixed, global organization and managing competing priorities effectively
Commitment to scientific integrity, compliance excellence, and continuous improvement
Preferred
Desirable certifications include ASQ –CQA, ASQ-CQE, ASQ-SWQE, ASQ-CQM
Advanced degree (MS, PhD, MBA, or equivalent) in a relevant discipline
Experience implementing or optimizing global Quality Management Systems (QMS) and digital tools
Lean Six Sigma, PMP, or similar certification demonstrating process improvement expertise
Benefits
Comprehensive benefits package including medical, dental, vision, life, and disability insurance
401(k) plan
Employee assistance program
Employee Stock Purchase Plan
Paid time off (including sick time)
Paid Holidays
Company
QuidelOrtho
> Bringing precision and passion in everything we do QuidelOrtho stands at the forefront of testing, tracking and disease analysis of health conditions ranging from HIV and hepatitis C to flu, strep and COVID-19.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Joe Busky, CPA
Chief Financial Officer
Michael Iskra
Executive Vice President and Chief Commercial Officer
Recent News
2025-12-18
2025-11-06
2025-11-06
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