Quality Lead, Assay Requirements & Specifications

RXinsider LTD.; 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 own the end-to-end quality inputs for a portfolio of assay-based medical devices. You will partner with R&D, Systems Engineering, Regulatory Affairs, Manufacturing, and Product Management to ensure compliant, scalable, and high-quality product development.

The role requires a Bachelor’s degree in Life Sciences or Engineering and 7+ years in Quality/Compliance in the Medical Device/IVD sectors, with

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline.
• 7+ years of experience in Quality, Compliance, or related fields within Medical Device/IVD/Biopharmaceutical industries.
• Strong knowledge of ISO 13485, FDA 21 CFR 820, and IVDR.
• Proven success leading Quality and Compliance initiatives aligned with business strategy.
• Excellent collaboration, influence, and communication across boundaries.
• Strong analytical and data-driven decision-making skills.
• Commitment to scientific integrity and continuous improvement.

Responsibilities

• Establish clear priorities, assign responsibilities, and allocate resources 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 requirements.
• Drive harmonization and standardization of Quality processes, procedures, and tools across sites and functions.
• Partner with Manufacturing, R&D, Regulatory Affairs, Supply Chain to integrate Quality principles through the product lifecycle.
• Promote continuous improvement by identifying simplification opportunities and digital enablement in the QMS.
• Maintain inspection readiness for regulatory audits and Notified Body engagements.
• Monitor Quality metrics, perform root cause analysis, and implement sustainable improvements.
• Coach and mentor Quality team members and support succession planning.
• Communicate Quality strategy, progress, and risk to senior leadership and stakeholders.
• Perform other duties as assigned.

Skills

Quality leadership

Regulatory collaboration

Analytical thinking

Cross-functional collaboration

Education

Bachelor’s degree in Life Sciences, Engineering, or related technical discipline

Job description

QuidelOrtho is seeking a Quality Lead, Requirements and Specifications Management (Assay) to own the end-to-end quality inputs for a portfolio of assay-based medical devices. You will partner with R&D, Systems Engineering, Regulatory Affairs, Manufacturing, and Product Management to ensure compliant, scalable, and high-quality product development.

The role requires a Bachelor’s degree in Life Sciences or Engineering and 7+ years in Quality/Compliance in the Medical Device/IVD sectors, with