Quality Assurance (QA) Specialist

Posted 2 Days Ago
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Chicago, IL, USA
Hybrid
55K-70K Annually
Junior
Artificial Intelligence • Big Data • Healthtech • Machine Learning • Analytics • Biotech • Generative AI
Tempus is a technology company leading the adoption of AI to advance precision medicine and patient care.
The Role
Supports quality assurance for client-specific projects in a regulated healthcare environment. Coordinates quality deliverables, timelines, risks, audits, CAPAs, NCRs, deviations, investigations, documentation, and compliance activities. Partners with project, product, operations, regulatory, client, and external teams; maintains QMS compliance; reviews documentation against international regulations; supports inspection readiness and process improvements. The role requires project coordination, client-facing communication, and familiarity with medical device, IVD, FDA, and laboratory quality standards.
Summary Generated by Built In

Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

Quality Assurance Specialist  

Passionate about precision medicine and advancing the healthcare industry?  Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical  information about the right treatments for the right patients, at the right time.  

Responsibilities:  

  • Serve as a QA partner for assigned client-specific projects, coordinating quality activities, deliverables, timelines, risks, and follow-up actions.
  • Collaborate with project, product development, operations, regulatory, and other cross-functional teams to integrate quality requirements into project plans and execution.
  • Act as a professional, responsive point of contact for clients and external partners on assigned quality matters.
  • Support client onboarding, pre-qualification, and project-specific quality questionnaires; collect, review, and coordinate supporting documentation.
  • Communicate project status, quality risks, decisions, and action items clearly to internal stakeholders and external client teams.
  • Contribute to project planning and governance, including tracking milestones, dependencies, deliverables, and quality-system commitments.
  • Manage and track NCRs, CAPAs, deviations, and related investigations, effectiveness checks, and follow-up activities associated with client projects.
  • Maintain awareness of applicable regulations and standards and communicate relevant changes or requirements to project stakeholders and management.
  • Comply with documented Quality Management System (QMS) procedures and complete assigned training on time.
  • Participate in internal, external, client, and regulatory audits as a project quality representative; support response development and closure of project-related observations.
  • Perform other duties and projects as assigned, with flexibility to support additional quality system areas.
  • Review QMS documentation against applicable regulations for international compliance  Remain up to date with applicable regulations to communicate changing requirements to  Management  
  • Help identify opportunities for process improvement related compliance and inspection readiness.   
  • Collaborate with cross-functional teams to collect documentation and support  compliance activities.  
  • Perform other duties and projects as assigned and ability to be flexible in supporting  various quality system areas 

Required Skills:  

  • Demonstrated project-management experience, including the ability to organize workstreams, manage timelines and dependencies, track deliverables, and escalate risks.
  • Client-facing and audit-facing experience, with the ability to communicate quality requirements and project status clearly and professionally.
  • Strong written and verbal communication skills and the ability to work effectively with stakeholders at different levels.
  • Self-motivated, flexible, detail-oriented, and able to work with minimal supervision.
  • Willingness to learn and apply applicable quality standards, regulations, and internal procedures.

Preferred Experience  

  • 1–3+ years of QA/QMS experience in a medical device, IVD, or other FDA-regulated environment.
  • Experience supporting product development, design controls, design transfer, verification/validation, or commercialization activities.
  • Experience supporting internal audits, external audits, client audits, and/or regulatory inspections.
  • Experience in a molecular testing laboratory or with laboratory-developed tests (LDTs).
  • Familiarity with applicable FDA regulations and quality standards for medical devices and IVDs.
CHI: $55,000-$70,000

The expected salary range may vary for other locations. Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.

We are 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. 

Skills Required

  • Demonstrated project-management experience organizing workstreams, managing timelines and dependencies, tracking deliverables, and escalating risks.
  • Client-facing and audit-facing experience communicating quality requirements and project status clearly and professionally.
  • Strong written and verbal communication skills with the ability to work effectively with stakeholders at different levels.
  • Self-motivated, flexible, detail-oriented, and able to work with minimal supervision.
  • Willingness to learn and apply applicable quality standards, regulations, and internal procedures.
  • 1-3+ years of QA or QMS experience in a medical device, IVD, or other FDA-regulated environment.
  • Experience supporting product development, design controls, design transfer, verification, validation, or commercialization activities.
  • Experience supporting internal audits, external audits, client audits, or regulatory inspections.
  • Experience in a molecular testing laboratory or with laboratory-developed tests (LDTs).
  • Familiarity with applicable FDA regulations and quality standards for medical devices and IVDs.

What the Team is Saying

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Tempus AI Compensation & Benefits Highlights

  • Healthcare Strength — Healthcare is considered solid, with PPO coverage often described as good and medical, dental, and vision options broadly available. Feedback suggests the overall health offering is a relative strong point despite mixed comments on premiums.
  • Leave & Time Off Breadth — Time off is frequently characterized as flexible, with reports of unlimited or generous PTO in many corporate roles. Feedback suggests policies can vary by team, but the offering is generally viewed favorably.
  • Wellbeing & Lifestyle Benefits — Workplace perks such as free meals/snacks, on-site amenities like a barista, gym discounts, and commuter benefits are commonly highlighted. Feedback suggests these lifestyle benefits add day-to-day value, especially at larger offices.

Tempus AI Insights

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The Company
HQ: Chicago, IL
3,775 Employees
Year Founded: 2015

What We Do

We bring together one of the world’s largest libraries of multimodal clinical and molecular data with a robust suite of AI tools to help physicians personalize care in real time, connect patients with therapies and clinical trials, and enable partners to accelerate discovery and development of new treatments. With ~8 million de-identified research records and 350+ petabytes of data, Tempus partners with more than half of U.S. oncologists and the majority of the top 20 global pharma companies. Our teams are pioneering work across oncology, neurology, psychiatry, cardiology, and beyond—transforming how care is delivered and therapies are developed. At Tempus, every role contributes to our mission: to help each patient benefit from the experiences of those who came before. For more information, visit tempus.com.

Why Work With Us

We’re looking for people who can change the world. People who question the status quo and refuse to shy away from tough problems. For builders who are never done building, and the learners who are never done learning. Passionate individuals with undying curiosity who want to take on one of the greatest challenges humanity has ever faced—head on.

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Tempus AI Offices

Hybrid Workspace

Employees engage in a combination of remote and on-site work.

Most of the team follows a hybrid policy, with some roles allowing for a fully remote arrangement and some roles being onsite only.

Typical time on-site: 3 days a week
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