Global Quality Lead, Assay Requirements & Specs

QuidelOrtho; Pompano Beach (FL); On-site; USD 135,000 - 175,000; Full time

Job summary

QuidelOrtho in the United States is seeking a Quality Lead, Requirements and Specifications Management (Assay) to drive end-to-end quality across a portfolio of assay-based medical devices. This global role partners with R&D, Systems Engineering, Regulatory, Manufacturing, and Product Management to ensure robust design inputs and compliant development.

The position requires a Bachelor's in Life Sciences or engineering, 7+ years in quality/compliance, and deep knowledge of ISO 13485, FDA 21 CFR

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related discipline.
• 7+ years in Quality, Compliance, or related fields in Medical Device/IVD/Biopharma.
• Knowledge of ISO 13485, FDA 21 CFR 820, IVDR.
• Proven success in leading Quality and Compliance initiatives aligned with strategy.
• Strong collaboration, influence, and cross-functional communication.
• Analytical skills and data-driven decision making.

Responsibilities

• 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.
• 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 team members 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.
• Perform other work-related duties as assigned.

Skills

Quality systems

Regulatory knowledge

Cross-functional collaboration

Data-driven decision making

Quality improvement

Education

Bachelor's degree in Life Sciences, Engineering, or related

Job description

QuidelOrtho in the United States is seeking a Quality Lead, Requirements and Specifications Management (Assay) to drive end-to-end quality across a portfolio of assay-based medical devices. This global role partners with R&D, Systems Engineering, Regulatory, Manufacturing, and Product Management to ensure robust design inputs and compliant development.

The position requires a Bachelor's in Life Sciences or engineering, 7+ years in quality/compliance, and deep knowledge of ISO 13485, FDA 21 CFR