Quality Assurance Specialist

Foresight Diagnostics Inc.•Boulder, CO

8h•$75,000 - $85,000•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.