Assay Quality Lead: Requirements & Specifications

QuidelOrtho; City of Rochester (NY); On-site; USD 135,000 - 175,000; Full time

Job summary

QuidelOrtho is seeking a Quality Lead, Requirements and Specifications Management (Assay) to drive the end-to-end requirements framework for assay-based medical devices.

You will define, own, and continuously improve quality systems, templates, and processes across the product lifecycle, partnering with R&D, Regulatory Affairs, Manufacturing, and Product Management to enable compliant and scalable development.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related technical discipline.
• 7+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries.
• Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR.
• 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.
• Commitment to scientific integrity, compliance excellence, and continuous improvement.

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 decisions

Analytical problem-solving

Education

Bachelor’s degree in Life Sciences/Engineering

MS/PhD preferred

Tools

QMS software

Job description

QuidelOrtho is seeking a Quality Lead, Requirements and Specifications Management (Assay) to drive the end-to-end requirements framework for assay-based medical devices.

You will define, own, and continuously improve quality systems, templates, and processes across the product lifecycle, partnering with R&D, Regulatory Affairs, Manufacturing, and Product Management to enable compliant and scalable development.