Quality Assurance Specialist

Location: Onsite in Boulder, Colorado

About our Company

Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.

About the Role

The QA Specialist supports laboratory quality compliance processes and helps to develop and implement the Quality Management System (QMS) to ensure adherence to CAP/CLIA, FDA GMP, and ISO 13485 regulations. The QA Specialist also supports the development of quality processes, investigating quality issues, and implementing continuous improvement activities to ensure that processes are scalable while maintaining Quality standards.

What You Will Bring

• Bachelor’s degree in life sciences or related technical field.

• Minimum of 5 years of Quality experience in a regulated environment.

• Knowledge of Quality System requirements, including ISO13485 and 21CFR820, and CAP/CLIA clinical regulations.

• Experience conducting Quality Assurance functions across investigations (NCR, CAPA), internal audits, release and reporting of results, SOP review and approval, document control, and risk management.

• Attention to detail with a strong ability to create and review technical documentation.

• Ability to interact with multiple disciplines and communicate clearly and effectively verbally and in writing.

• Ability to work independently and utilize good problem-solving skills.

• Ability to multitask and work within a fast-paced dynamic team environment.

What You Will Do

• Support the management of NCR/CAPA, laboratory support, supplier approvals, document control, training, internal audits, and other QMS responsibilities.

• Perform document management functions within the eQMS system.

• Coordinate document change orders, and facilitates review, approval, and retention activities per applicable regulations and SOPs.

• Supports Change Management activities with cross-functional teams.

• Provide direct QA support to Laboratory Operations and process development.

• Ensure the Quality System elements are in compliance with the regulations, and help to create and/or drive improvements in the creation of Standard Operating Procedures.

• Develops, implements, and evaluates tools, systems, and methods for laboratory process improvement and conformance.

• Identifies and supports quality test methods, inspection criteria, risk assessments, and other processes for new products to ensure compliance to regulatory standards.

• Perform other duties as assigned by supervisor.

Physical Requirements

This position requires the ability to communicate clearly and accurately verbally and in writing, to sit for extended periods, stand, and walk, and to utilize basic office equipment including a computer, keyboard and mouse. This position will lift up-to 10 pounds regularly, and up to 20 pounds occasionally. The position works in a climate-controlled environment, primarily indoors in an office setting.

Compensation & Benefits

This role is hiring at an annual salary of $75,000 - $95,000 and is bonus eligible. Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, health savings accounts, flexible spending accounts, and a 401k with company match.

The application deadline for this job opening is November 30, 2025.

You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.