Quality Assurance Specialist at Foresight Diagnostics Inc.

Boulder, Colorado, United States -

Full Time

Start Date

Immediate

Expiry Date

29 May, 26

Salary

85000.0

Posted On

28 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

NCR/CAPA Processes, Document Management, eQMS System, Document Change Orders, Document Control, Training Programs, Change Management, Internal Audits, SOP Development, Risk Assessments, Supplier Approval, ISO 13485, 21 CFR 820, CAP/CLIA Regulations, Risk Management, Technical Documentation

Industry

Biotechnology Research

Description

Location: Boulder, CO · Full-Time · On-Site Quality isn’t a checkpoint at the end of the process - it’s woven into everything we do. At Foresight Diagnostics, now part of Natera, the integrity of our MRD cancer detection platform starts with the systems and standards our Quality team maintains every day. We’re looking for a Quality Assurance Specialist who is ready to be a key part of that foundation - someone who cares deeply about getting the details right because they understand what those details mean for patients. ABOUT FORESIGHT DIAGNOSTICS Foresight Diagnostics is a molecular diagnostics company pioneering non-invasive cancer detection through highly sensitive, cell-free DNA-based liquid biopsy technologies. Our proprietary methods - originally developed at Stanford University - are designed to detect smaller tumors earlier and enable more personalized treatment strategies for patients with cancer. We sit at the intersection of molecular biology, bioinformatics, and next-generation sequencing (NGS), and we translate rigorous science into clinically meaningful solutions. Following our acquisition by Natera, we now combine the agility of a mission-driven startup with the scale and resources of a global leader in cell-free DNA testing. It’s an exciting moment to join us. Headquartered in Boulder, Colorado, our team operates in a high accountability, collaborative environment where quality and continuous improvement aren’t just values - they’re how we work every day. WHY THIS ROLE EXISTS Our Quality Management System is the backbone of clinical compliance across our laboratory and product operations. As we scale, we need a skilled QA Specialist who can keep that backbone strong - supporting investigations, driving documentation processes, enabling cross-functional teams, and helping us build quality infrastructure that grows with us. This is a hands-on role with direct impact on how well our organization functions and how confidently we can operate in a regulated clinical environment. WHAT YOU’LL DO You’ll be embedded in the day-to-day operations of our QMS, partnering closely with Laboratory Operations, process development teams, and cross-functional stakeholders. Your work will span: Supporting the management and execution of NCR/CAPA processes - from investigation through resolution - ensuring issues are thoroughly documented, root causes identified, and corrective actions closed out effectively. Performing document management functions within the eQMS system, including coordinating document change orders and facilitating review, approval, and retention activities per applicable regulations and SOPs. Providing direct QA support to Laboratory Operations, helping ensure day-to-day lab processes are compliant and continuously improving. Overseeing document control and training programs, ensuring full lifecycle, audit readiness, and role-based training adherence across the organization. Supporting Change Management activities across cross-functional teams, ensuring changes are assessed, documented and implemented in a controlled manner. Conducting internal audits to evaluate QMS compliance and identify opportunities for process improvement. Developing and revising SOPs to reflect current practices and regulatory requirements, driving clarity and consistency across the organization. Evaluating and implementing tools, systems, and methods that improve laboratory process efficiency and conformance. Identifying and supporting quality test methods, inspection criteria, and risk assessments for new products and processes. Supporting supplier approval activities and laboratory quality compliance processes as needed. WHAT YOU’LL BRING Required 5+ years of Quality Assurance experience in a regulated environment - clinical laboratory, diagnostics, medical device, or pharmaceutical. Solid working knowledge of quality system requirements including ISo 13485, 21 CFR 820, and CAP/CLIA clinical regulations. Hands-on experience across core QA function: NCR/CAPA investigations, internal audits, document control, SOP development, and risk management. Exceptional attention to detail with demonstrated ability to create, review, and improve technical documentation. Strong communicator - equally comfortable, presenting to scientists, lab staff, and leadership, both verbally and in writing. Self-directed and comfortable managing multiple priorities in a fast-moving, cross-functional environment. Bachelor’s degree in life sciences, engineering, or a related technical field. Preferred Experience working with an electronic QMS (eQMS) platform. Background in molecular diagnostics, liquid biopsy, NGS, or oncology-focused laboratory settings. Familiarity with FDA GMP requirements in a clinical or IVD context. Quality certifications such as CQA, CQE, or equivalent. WHY JOIN US This is a role where your work shows up in tangible ways - in cleaner processes, stronger compliance, better documentation, and ultimately in the reliability of cancer detection results that clinicians trust. You’ll be part of cancer detection results that clinicians trust. You’ll be a part of a Quality team that is building intentionally, not reactively, and you’ll do it from one of the best cities in the country for outdoor living and biotech talent. We promote from within, and want to see the people who do great work here grow alongside the company. If you’re looking for a place where quality is valued - not just as a function but as a mindset - this is it. COMPENSATION, BENEFITS & EQUAL OPPORTUNITY This role offers a competitive annual base compensation of $75,000 - $85,000 commensurate with experience, equity participation, and a comprehensive benefits package including: Medical, dental, and vision Flexible PTO and paid holidays Parental leave 401(k) with company match You will be working on interesting problems with extremely high impact. We promote the professional development of our teams and 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. PHYSICAL REQUIREMENTS This role is primarily office-based in a climate controlled environment. It requires the ability to communicate clearly, verbally and in writing, work at a computer for extended periods and occasionally lift up to 20 lbs. Ready to make an impact in cancer diagnostics? Apply below - we’d love to hear from you.

Responsibilities

The specialist will support the management and execution of NCR/CAPA processes, ensuring thorough documentation and effective corrective action closure. Responsibilities also include performing document management functions within the eQMS, overseeing document control and training programs, and supporting change management activities.