Senior Clinical Lab QA Lead – Regulatory & QMS

Regulatory Jobs; Madison (WI); On-site; USD 87,000 - 173,000; Full time

Benefits offered by this job

Free medical coverage in HIP PPO plan

Excellent retirement savings plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott, a global healthcare leader, is seeking a Lead Clinical Lab QA Specialist in Madison, WI to manage the Quality Management System for Exact Sciences Laboratories and ensure regulatory compliance. The role supports cross-functional teams and drives continuous improvement in a highly regulated setting.

The position requires a scientific bachelor’s degree, 4+ years QA experience, and familiarity with FDA/CLIA/HIPAA standards; Epic and MS Office proficiency is preferred.

Qualifications

• Bachelor’s degree in a scientific field related to QA duties.
• 4+ years of professional work experience in quality assurance in a regulated environment.
• 3+ years developing and implementing quality indicators in a lab setting.
• 2+ years leading process, project implementation, or improvement.
• 2+ years managing, monitoring, and maintaining Quality Management Systems (QMS).
• Experience with FDA/CLIA/HIPAA regulatory environments and associated standards.
• Experience with Epic or other electronic health record systems and MS Office.

Responsibilities

• Develop, implement, and maintain the Quality Management System for Exact Sciences Laboratories.
• Ensure compliance with clinical laboratory regulatory requirements.
• Monitor effectiveness of the quality system and drive continuous improvement initiatives.
• Lead cross-functional projects with internal and external partners.
• Coordinate investigations of quality concerns and provide guidance to teams.

Skills

Communication skills

Project management

Leadership by influence

Regulatory knowledge

Attention to detail

Data analysis

Education

Bachelor’s degree in a scientific major

Advanced degree in a scientific field

Tools

Epic EHR software

Microsoft Office

Job description

Abbott, a global healthcare leader, is seeking a Lead Clinical Lab QA Specialist in Madison, WI to manage the Quality Management System for Exact Sciences Laboratories and ensure regulatory compliance. The role supports cross-functional teams and drives continuous improvement in a highly regulated setting.

The position requires a scientific bachelor’s degree, 4+ years QA experience, and familiarity with FDA/CLIA/HIPAA standards; Epic and MS Office proficiency is preferred.