Quality Assurance (QA) Specialist

Tempus AI•Chicago, IL

2d•$55,000 - $70,000

About The Position

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.

Requirements

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.

Nice To Haves

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.

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