Senior Lab QA & Quality Management Lead

Thornton Tomasetti; Madison (WI); On-site; USD 87,000 - 173,000; Full time

Benefits offered by this job

Free medical coverage via HIPAA HIPPO

High employer contribution retirement

Tuition reimbursement

FreeU education benefit

Job summary

Abbott in Madison, WI, seeks a Lead Clinical Lab QA Specialist to develop, implement, and maintain the Quality Management System for the Exact Sciences Laboratories, ensuring compliance with clinical laboratory regulations. You will monitor effectiveness, drive continuous improvement, and educate staff on procedures and regulations.

The role requires leading QA meetings, presenting quality metrics to senior leadership, and coordinating cross-functional initiatives across lab teams and external

Qualifications

• Bachelor’s degree in a scientific major or field related to the essential duties of the position.
• 4+ years of professional work experience in quality assurance in a regulated environment.
• 3+ years of experience developing, establishing, and implementing quality indicators within a laboratory environment.
• 2+ years of direct experience leading process and project implementation, management, or improvement.
• 2+ years of experience managing, monitoring, and maintaining Quality Management Systems (QMS).
• Demonstrated experience leading quality management meetings with senior leadership, including gathering, analyzing, and presenting key quality metrics, performance indicators, and supporting data to drive discussions and continuous improvement initiatives.
• Demonstrated understanding and professional working knowledge of FDA, CLIA, CAP, HIPAA, or other applicable regulatory entities and standards.
• Proficient in Epic healthcare software or other electronic patient medical record (ePHI) software/system.
• Proficient in Microsoft Office programs.
• Demonstrated aptitude for learning new processes and software.
• Demonstrated ability to collaborate across functions with both internal and external stakeholders, and to communicate ideas and opinion in a proactive and professional manner.
• Exceptional written and verbal communication skills, excellent attention to detail and organization skills.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Responsibilities

• Independently manage multiple, complex projects simultaneously within defined timelines, prioritizing as necessary, with minimal instruction or oversight.
• Identify, develop, design, and assist with coordinating improvements.
• Provide subject matter expertise, guidance, and recommendations to Lab QA team members and other Exact Sciences Lab teams/sites while leading through influence, informal leadership, and best practice advocacy.
• Investigate, document, and resolve complex quality assurance related concerns received from various lab teams, enterprise teams, and 3rd party vendors.
• Utilize project management experience to initiate and lead cross‑functional projects with both internal and external partners.
• Ability to interface, work effectively, and conduct themselves in the highest professional manner with all levels of the organization, vendors, customers, etc.
• Ability to work in a team environment and adapt to and embrace change in projects, workload, and circumstances effectively; able to respond to new information quickly.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company’s Quality Management System policies and procedures.
• Maintain regular and reliable attendance.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 80% of a typical working day.
• Ability and means to travel between work locations.
• Ability to maintain confidential information.

Skills

Attention to detail

Written communication

Verbal communication

Cross-functional collaboration

Project management

Education

Bachelor's degree in a scientific field

Tools

Epic

ePHI software

Microsoft Office

Job description

Abbott in Madison, WI, seeks a Lead Clinical Lab QA Specialist to develop, implement, and maintain the Quality Management System for the Exact Sciences Laboratories, ensuring compliance with clinical laboratory regulations. You will monitor effectiveness, drive continuous improvement, and educate staff on procedures and regulations.

The role requires leading QA meetings, presenting quality metrics to senior leadership, and coordinating cross-functional initiatives across lab teams and external