Clinical Lab QA & Quality Systems Lead

American Society for Quality; Madison, Northern (WI, KY); Hybrid; USD 87,000 - 173,000; Full time

Job summary

Abbott is seeking a Lead Clinical Lab QA Specialist to develop, implement, and maintain the Quality Management System for the Exact Sciences Laboratories, ensuring compliance with FDA, CLIA, CAP, HIPAA, and other regulatory requirements. The role focuses on monitoring system effectiveness, supporting continuous improvement, and educating workforce on procedures and regulations.

You will independently manage multiple cross-functional projects, provide SME guidance to QA teams and lab sites,

Qualifications

• Bachelor’s degree in a scientific major.
• 4+ years of QA experience in a regulated environment.
• 2+ years leading process and project implementation.
• Knowledge of FDA, CLIA, CAP, HIPAA, or other regulations.
• Proficient in Epic or other ePHI software.
• Proficient in Microsoft Office programs.
• Ability to collaborate across functions and communicate professionally.
• Excellent written and verbal communication; detail-oriented.
• Authorized to work in the United States without sponsorship.

Responsibilities

• Independently manage multiple, complex projects with defined timelines.
• Identify, develop, design, and coordinate improvements.
• Provide SME guidance to Lab QA teams and sites.
• Investigate, document, and resolve quality assurance concerns.
• Lead cross-functional projects with internal and external partners.
• Interface professionally with all levels of the organization and vendors.
• Work in a team environment and adapt to change.
• Uphold Quality Management System policies and procedures.
• Travel between work locations.

Skills

Quality assurance experience

Regulatory knowledge

Cross-functional collaboration

Attention to detail

Professional communication

Education

Bachelor’s degree in a scientific field

Tools

Epic software

Microsoft Office

Job description

Abbott is seeking a Lead Clinical Lab QA Specialist to develop, implement, and maintain the Quality Management System for the Exact Sciences Laboratories, ensuring compliance with FDA, CLIA, CAP, HIPAA, and other regulatory requirements. The role focuses on monitoring system effectiveness, supporting continuous improvement, and educating workforce on procedures and regulations.

You will independently manage multiple cross-functional projects, provide SME guidance to QA teams and lab sites,