Senior Manager, Design Quality

Foresight Diagnostics Inc.•Boulder, CO

3d•$155,000 - $165,000•Hybrid

About The Position

Every quality system we build, maintain, and continuously improve brings us one step closer to a world where cancer recurrence is caught before it takes hold. At Foresight Diagnostics - now part of Natera, Inc. - our work in minimal residual disease (MRD) detection is changing what’s possible for patients and oncologists alike. We’re looking for a Senior Manager of Design Quality who is ready to help us support the systems and teams that make that happen. 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, next-generation sequencing (NGS), and bioinformatics 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 As we scale our MRD platform towards broader clinical and commercial deployment, the integrity of our design quality systems is foundational to everything we do. This is a leadership role with real ownership - you’ll shape how quality engineering functions across product development, guide a team of talented quality engineers, and ensure that the systems we build meet the highest regulatory and clinical standards. The work you lead directly supports the ability to produce reliable test results that oncologists and patients depend on.

Requirements

10+ years of experience in quality engineering or quality leadership, with demonstrated lifecycle ownership of regulated products.
Proven experience leading or hosting regulatory audits (CLIA, NYDOH, ISO 15189, ISO 13485, IEC 62304, ISO 27001, FDA CFR).
Strong track record managing and developing teams in a regulated product environment.
Bachelor’s or advanced degree in engineering, biomedical engineering, or a closely related field.

Nice To Haves

Background in molecular diagnostics, oncology or liquid biopsy - familiarity with cfDNA, NGS, or tumor-informed assays is a genuine plus.
Experience in FDA Class I, II or III medical devices, or EU IVDR Class A, B, or C environments in a quality leadership capacity.
Regulatory Affairs exposure or cross-functional QMS partnership with RA teams.
PMP, Lean, or Six Sigma certification; quality certifications such as CQE or CQPA.

Responsibilities

Owning and continuously improving the Quality Management System, with a particular focus on the product development lifecycle - from product quality planning, design control, and risk management through post-market monitoring and investigations.
Overseeing the development of comprehensive test plans and validation strategies to ensure product compliance across the product portfolio.
Driving design and process verification and validation efforts cross-functionally, partnering closely with software, reagent manufacturing, supply chain, clinical lab, and regulatory teams.
Supporting quality event processes, such as CAPA, nonconformance, and complaint handling.
Developing and maintaining robust risk management frameworks that protect patients and keep our programs on track.
Managing a team of quality engineers responsible for design controls, product risk management, providing mentorship, career development, and technical direction.
Maintaining the quality manual, SOPs, and new/revisions to applicable standards - and making sure they’re understood and followed, not just filed.
Leading audit readiness and supporting regulatory inspections, including crafting well-considered responses to findings and observations.
Collaborating with site leadership on training program development and oversight.
Reporting on process efficiency through regular internal audits and metrics that drive real improvement - not just compliance theater.
Other duties, as assigned.