Remote, Boulder Colorado, United States

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 Quality Team: Come join a growing Quality team that is eager to incorporate Quality principles into the framework of an entire organization! We are building intuitive compliance systems needed to ensure that regulatory requirements are met while helping to ensure the scalability of our operations.

About the Role: The Software Quality Engineer will be responsible for ensuring software systems supporting cross functional teams and Foresight’s products are developed, implemented and maintained in compliance with ISO27001, IEC62304, ISO13485, and clinical regulations (CAP, CLIA, ISO15189). This position will work cross functionally with internal members of the clinical laboratory, R&D, IVD, bioinformatics, product development, and regulatory teams predominantly on software quality requirements, but may also be asked to participate in additional QMS activities to support cross-functional projects and requirements. Externally, this position will participate in audits with our regulatory bodies. This is a full-time position working standard business hours, but may require the flexibility to work diverse schedules, including evenings, weekends, and holidays. This position reports to the Director of Quality.

What You Will Bring:

• 3-5 years of experience working in a software quality-related role in a regulated environment, such as FDA, ISO, or CAP/CLIA

• Bachelor’s degree in software engineering, computer science, information technology, or related.

• Experience executing IEC62304 software design lifecycle development in conjunction with ISO13485 design control requirements

• Experience defining process requirements for, and conducting, software validation

• Demonstrated ability to verify software test execution (automation and manual)

• Proven ability to deliver actionable results to complex problems

• Ability to deliver on end-to-end projects with a high level of autonomy

• Exceptional interpersonal skills with ability to work inclusively and collaboratively with a diverse population

What You Will Do:

• Develop and implement comprehensive test plans and test cases to assess compliance of products outlined in the product roadmap and coordinate with cross functional teams on timely remediation

• Execute test plans, automated and manual, to confirm quality conformance to predefined specifications and quality deliverables, and present associated documentation/reports to cross functional teams and leadership for review

• Lead cross functional collaboration in designing and implementing validation plans for Foresight’s suite of software systems

• Create and revise standard operating procedures (SOPs), as needed, to define software quality requirements and release readiness operations, and shepherd these documents through the design and documentation control processes

• Develop risk analysis tools and risk management plans for Foresight’s suite of software systems

• Closely monitor, maintain, and improve the efficiency of processes via regular audits and internal reporting

• Resolve end user issues via investigation and resolution, to include management of the NCR and CAPA processes and metrics

• Ensure all software quality practices are in compliance with Foresight’s SOPs and applicable regulations

This is a remote position offering a salary between $112,000-135,000, generous equity, along with medical, dental and vision benefits. 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.