Quality Assurance Specialist

Location:Boulder COFull-Time On-Site Preferred or Remote

Quality isnt a checkpoint at the end of the process - its 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. Were 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. Its an exciting moment to join us.

Headquartered in Boulder Colorado our team operates in a high accountability collaborative environment where quality and continuous improvement arent just values - theyre 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 YOULL DO

Youll 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 YOULL 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 ISOCFR 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.

• Bachelors 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. Youll be part of cancer detection results that clinicians trust. Youll be a part of a Quality team that is building intentionally not reactively and youll 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 youre 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 $75000 - $85000 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 - wed love to hear from you.

OUR OPPORTUNITY

Natera is a global leader in cell-free DNA (cfDNA) testing dedicated to oncology womens health and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer healthier lives.

The Natera team consists of highly dedicated statisticians geneticists doctors laboratory scientists business professionals software engineers and many other professionals from world-class institutions who care deeply for our work and each other. When you join Natera youll work hard and grow quickly. Working alongside the elite of the industry youll be stretched and challenged and take pride in being part of a company that is changing the landscape of genetic disease management.

WHAT WE OFFER

Competitive Benefits - Employee benefits include comprehensive medical dental vision life and disability plans for eligible employees and their dependents. Additionally Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave 401k benefits commuter benefits and much more. We also offer a generous employee referral program!

For more information visit .

Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment and welcome people of different backgrounds experiences abilities and perspectives. Inclusive collaboration benefits our employees our community and our patients and is critical to our mission of changing the management of disease worldwide.

All qualified applicants are encouraged to apply and will be considered without regard to race color religion gender gender identity or expression sexual orientation national origin genetics age veteran status disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories consistent with applicable laws.

If you are based in California we encourage you to read this important information for California residents.

Link: be advised that Natera will reach out to candidates with a @ domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously and will collaborate with law enforcement authorities to prosecute any related cyber crimes.

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