Quality Assurance Specialist

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

Job summary

Tempus AI in Chicago, IL is seeking a QA Specialist to support quality activities for incidents, deviations, NCs, and CAPAs per FDA QSR and ISO 13485. This onsite role requires Tuesday-Saturday or Sunday-Thursday work schedules and a clinical laboratory/diagnostic background.

Responsibilities include managing NC/CAPA investigations, regulatory reporting support, and driving continual improvements to quality systems. Strong communication and leadership are essential.

Qualifications

• Bachelor’s Degree in Engineering or Science.
• 1 to 3+ years of QA experience in a clinical laboratory/medical device/Diagnostic company.
• Working knowledge of 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.
• Strong communication, influencing, negotiating and collaboration skills.
• This will be an on-site position.

Responsibilities

• Process and manage issues including deviations, NCs, and CAPAs under FDA 21 CFR 820, ISO 13485, CAP/CLIA and other applicable quality system regulations and standards.
• Support process improvements to the issue/incident reporting framework, ensuring systems are streamlined and aligned.
• Collaborate with Regulatory on health authority reporting as necessary.
• Assist in NC/CAPA activities, including investigations, root cause analysis, and closure.
• Drive ownership of issues/incidents to achieve final resolution and provide training to owners.
• Support departmental goals for deviations, NC and CAPA processes with minimal supervision.
• Identify trends and provide metrics to drive root cause analysis and corrective actions.
• Participate as NC/CAPA SME during internal and external audits.
• Lead or support other duties as assigned.

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. 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.

Responsibilities Include The Following. Other Duties May Be Assigned.

• 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. 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.