Sr. Clinical Lab Quality Data Engineer

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Position Overview

The Senior Clinical Lab Data Quality Engineer plays a critical role in ensuring accuracy, consistency, and integrity of laboratory data with a strong focus on molecular and next-generation sequencing (NGS) quality control processes. This role integrates advanced data analytics, statistical methods, and automation tools to support and enhance Quality Control (QC) systems across clinical lab operations.

Key responsibilities include the development, validation, training and implementation of QC tools to improve data monitoring, process efficiency, and regulatory readiness. The Sr. Engineer applies technical knowledge and collaborates cross-functionally to support investigations, root cause analysis, and continuous improvement efforts aimed at enhancing data quality and operational efficiency.

Essential Duties

Include, but are not limited to, the following:

• Maintain an understanding of applicable software changes and updates to systems used by QC and other teams.
• Independently perform QC functions and data analysis.
• Maintain functionality of QC data analysis tools and ensure updates are validated.
• Demonstrate strong proficiency in laboratory QC processes, including their development, implementation, and execution.
• Lead cross-functional meetings and projects independently, both virtually and in person, and act as SME and consultant for QC considerations across the organization.
• Bridge technical QC knowledge with business needs, translating cross-team processes and training staff accordingly.
• Demonstrate working knowledge of molecular and NGS assay-related QC methods and is skilled in routine and complex laboratory techniques, with minimal supervision.
• Understand laboratory theory, instrumentation, and testing principles for troubleshooting and validation.
• Assist in aligning QC initiatives with operations goals, ensuring accurate data delivery to all stakeholders.
• Act as a mentor to peers by sharing expertise in data analysis, software tools, and quality control best practices.
• Assist in SOP development and review; contributes to policy design and implementation.
• Ability to properly document and present data through methods such as root cause analysis, troubleshooting investigations, and data analysis.
• Support lab readiness for inspections and proficiency testing through documentation and regulatory compliance.
• 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.
• Exceptional written and verbal English communication skills and strong attention to detail.
• Regular and reliable attendance with schedule flexibility.
• Adapts to shifting priorities and locations while ensuring consistent performance.
• Ability to travel within and outside of Madison laboratory locations.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability to work on a computer and phone simultaneously.
• Ability to comply with any applicable personal protective equipment requirements.

Minimum Qualifications

• Bachelor's degree in clinical laboratory science, chemical or biological sciences or related field.
• 4+ years of experience in a clinical laboratory setting.
• 2+ years of experience performing, reviewing, and understanding QC on a routine basis.
• 1+ years of experience using statistical methods and programs to assess laboratory testing.
• Proficient in using statistical tools and platforms such as JMP, Microsoft Excel VBA, and other lab specific LIS systems.
• Demonstrated ability to respond to stakeholder requests in a professional and timely manner.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.
• Moderate understanding of programming languages.
• Moderate understanding of regulatory requirements related to quality control.
• Moderate understanding of data visualization.
• Moderate understanding of statistical methods and interpretation.

Preferred Qualifications

• MBA, MHA, or MS.
• 6+ years of relevant experience in a clinical laboratory setting.
• 6+ years of relevant experience in a molecular diagnostic laboratory.
• 3+ years of relevant experience within the Exact Sciences Technical Laboratory.
• 2+ years of experience formally or informally leading people or initiatives in a clinical laboratory setting.
• ASCP certification.
• 1+ year of programming experience specifically those related to JMP (SQL) and other systems the QC team may use.
• 1+ year of experience working on tasks dependent on regulatory requirements as it relates to quality control.
• 1+ year of experience working with VBA for Excel and PowerPoint.
• 1+ year of experience working on data visualization.
• 1+ year of experience working with statistical methods and interpretations.

Salary Range:

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.

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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law.

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