Tempus AI Inc.
Quality Assurance Specialist
Tempus AI Inc., Chicago, Illinois, United States, 60290
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:
Assist with certifications and self-certifications process of various Tempus products including CE-mark and IVDR regulatory process
Completions of Technical Dossiers
Identity self-certification or notified body certification path of products
Assist with completion of Declaration of Conformity (EC DoC) of products
Communication with Tempus’ Notified Body as needed
Collaborate cross-functionally with Quality, Regulatory, R&D, Engineering, Supply Chain and Operations for continued support of International Regulatory Compliance, maintenance, and improvement of the Quality Management System (QMS).
Support Lead Auditor with audit functions
May be required to participate in conducting internal audits under the direction of the Lead Auditor
Assist with completion of partnership pre-qualification questionnaires
Oversee drafting of internal and external audit responses to closure
Administrative audit functions as needed
Lead partnership/client audits.
Comply with documented Quality Management System procedures
Completion of assigned training on time
Perform other duties and projects as assigned
Review QMS documentation against applicable regulations for international compliance
Remain up to date with applicable regulations to communicate changing requirements to Management
Assist with inspection readiness efforts and external audits
Offer improvement strategies to existing processes
Managing and hosting external audits including regulatory inspections and CAP/CLIA Inspections.
Required Skills:
Superb organizational and follow through skills
Strong interpersonal skills in the areas of written and verbal communication
Must be creative, flexible, and able to prioritize and handle multiple projects concurrently
Must be self-motivated and have the ability to work with minimal supervision
Minimum of 4 years of QMS experience in the FDA regulated industry - medical devices or IVDs
Bachelor’s degree required preferably in a life science discipline
Preferred Experience:
Some QA experience in a molecular testing laboratory (LDTs) is a plus
Interest in obtaining Auditor certification is a plus
#J-18808-Ljbffr
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:
Assist with certifications and self-certifications process of various Tempus products including CE-mark and IVDR regulatory process
Completions of Technical Dossiers
Identity self-certification or notified body certification path of products
Assist with completion of Declaration of Conformity (EC DoC) of products
Communication with Tempus’ Notified Body as needed
Collaborate cross-functionally with Quality, Regulatory, R&D, Engineering, Supply Chain and Operations for continued support of International Regulatory Compliance, maintenance, and improvement of the Quality Management System (QMS).
Support Lead Auditor with audit functions
May be required to participate in conducting internal audits under the direction of the Lead Auditor
Assist with completion of partnership pre-qualification questionnaires
Oversee drafting of internal and external audit responses to closure
Administrative audit functions as needed
Lead partnership/client audits.
Comply with documented Quality Management System procedures
Completion of assigned training on time
Perform other duties and projects as assigned
Review QMS documentation against applicable regulations for international compliance
Remain up to date with applicable regulations to communicate changing requirements to Management
Assist with inspection readiness efforts and external audits
Offer improvement strategies to existing processes
Managing and hosting external audits including regulatory inspections and CAP/CLIA Inspections.
Required Skills:
Superb organizational and follow through skills
Strong interpersonal skills in the areas of written and verbal communication
Must be creative, flexible, and able to prioritize and handle multiple projects concurrently
Must be self-motivated and have the ability to work with minimal supervision
Minimum of 4 years of QMS experience in the FDA regulated industry - medical devices or IVDs
Bachelor’s degree required preferably in a life science discipline
Preferred Experience:
Some QA experience in a molecular testing laboratory (LDTs) is a plus
Interest in obtaining Auditor certification is a plus
#J-18808-Ljbffr