Quality Assurance Specialist

Tempus AI, Inc.; Chicago (IL); On-site; USD 55,000 - 70,000; Full time

Benefits offered by this job

Benefits including incentive comp

Restricted stock units

Medical and other benefits

Job summary

Tempus AI, Inc. in Chicago is hiring a Quality Assurance Specialist to support FDA QSR, ISO 13485 and CLIA/CAPAs in a clinical lab/diagnostic setting. You will manage NCs, CAPAs, deviations and investigations, ensuring alignment with global quality standards.

Responsibilities include trend analysis, cross-functional collaboration with Regulatory, and driving improvements to incident reporting and corrective actions while maintaining timely training and closure of issues.

Qualifications

• Bachelor's degree in engineering or science required.
• 1 to 3+ years of QA experience in a clinical laboratory/medical device/diagnostic company.
• Working knowledge of medical device and regulatory standards (FDA 21 CFR 820, ISO 13485, IVDD).
• QA experience in a clinical molecular testing laboratory (LDTs) required.
• Familiar with deviations, NC and CAPA processes.
• Strong communication, collaboration and leadership abilities.

Responsibilities

• Support quality activities related to incidents, deviations, NCs and CAPAs per FDA/ISO requirements.
• Assist CLIA/CAP regulatory compliance for clinical laboratories.
• Manage issue tracking, investigations and root cause analysis.
• Collaborate cross-functionally to improve the incident reporting framework.
• Assist regulatory reporting and drive timely closure and training.

Skills

QA experience

Regulatory knowledge

Communication skills

Leadership

Education

Bachelor's Degree in Engineering or Science

Job description

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.

Please note: This position is onsite in Chicago and requires you to work Tuesday-Saturday or Sunday-Thursday.

Responsibilities

• The Quality Assurance Specialist plays an integral role in supporting quality activities related to incidents and issues, including deviations, nonconformances (NC) and corrective and preventive actions (CAPA) in accordance with FDA QSR (Quality System Regulation), ISO 13485, and other applicable global regulations.
• This individual also supports the QMS activities that comply with CLIA/CAP requirements for the clinical laboratories.
• Responsible for processing and managing issues/incidents that include deviations, NCs, and CAPAs, as well as ensuring compliance to FDA 21 CFR 820, ISO 13485, CAP/CLIA and other applicable quality system regulations and standards.
• Participate in process improvements to the issue/incident reporting framework by helping identify areas for improvement, simplification, and standardization, ensuring that the various systems are streamlined and aligned.
• Collaborate with Regulatory on appropriate health authority reporting, as necessary.
• Assist in NC/CAPA activities, including investigations, root cause analysis, effectiveness verification, and closure by establishing cross-functional relationships and collaborations with functional owners.
• Drive ownership of issues/incidents to lead to final resolution and closure by providing training and guidance to owners.
• Responsible for assisting in activities to ensure departmental goals for deviations, NC and CAPA processes are achieved.
• Identify trends and provide metrics to drive root cause analysis and corrective actions to prevent the recurrence of quality issues.
• Participate if needed as a NC and CAPA subject matter expert during internal and external audits.
• Lead and/or support other duties as assigned.

Required Education & Experience

• Bachelor’s Degree in Engineering or Science field.
• 1 to 3+ years of QA experience in a clinical laboratory/medical device/Diagnostic company.
• Working knowledge of medical device / in vitro diagnostic regulations (e.g., FDA 21 CFR 820, ISO 13485, IVDD, and other applicable quality and regulatory standards).
• QA experience in a clinical molecular testing laboratory (LDTs) is required.
• Working knowledge of the deviations, NC and CAPA processes.
• Strong communication (written and verbal), influencing, negotiating and collaboration skills.
• Ability to work through complex issues and differences in a creative, constructive, and diplomatic manner.
• Ability to manage multiple tasks with limited supervision.
• Ability to demonstrate leadership in helping improve quality processes and create efficiencies for business needs.
• Ability and willingness to work independently and take initiative to ensure timely action on issues.

This will be an on-site position.

Illinois Pay Range: $55,000-$70,000. The expected salary range may vary for other locations. Actual salary may vary based on qualifications and experience.

Benefits

• 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.

Tempus was founded in August of 2015 by Eric Lefkofsky, after his wife was diagnosed with Breast Cancer. Shortly after he founded the company in an effort to bring the power of technology and artificial intelligence to cancer care, he convinced Ryan Fukushima to join as the company’s first employee. Ryan and Eric began assembling a world class team, focused on building the first version of a platform capable of ingesting real time healthcare data in an effort to personalize diagnostics. We built the platform for oncology and have expanded it to neuropsychiatry, cardiology, infectious disease (through COVID), and radiology. Despite our rapid growth, our mission remains the same—to help make sure patients are on the right drug at the right time, so they can live longer and healthier lives. We’re looking for people who can change the world. Who question the status quo and don’t shy away from tough problems. For the builders who are never done building and the learners who are never done learning. We’re looking for passionate people with undying curiosity. Those who want to attack one of the most challenging problems mankind has ever faced. Head on.