Tempus AI
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Senior Quality Engineer - PMS
role at
Tempus AI
Recent advancements in technology have enabled AI to impact clinical care significantly. Tempus' platform connects real-world evidence to deliver real-time insights to physicians, aiding in selecting appropriate treatments for patients.
We seek a Senior Quality Engineer – PMS with expertise in FDA Quality System Regulation (21 CFR 820), ISO 13485, and experience with CAP/CLIA and New York State regulations, especially in laboratory-developed tests (LDTs). The role involves supporting quality metrics, resolving non-conformances, leading Post-Market Surveillance activities, and ensuring compliance across global markets.
Responsibilities
Assist in Quality Data trending and monitoring within QA
Develop reporting strategies and metrics for Quality Management Review
Implement metric reporting across operations
Lead Major incident management and cross-functional resolution
Support Post Market Surveillance procedures and processes
Trend control limits and assay quality data with Operations
Lead international product risk management activities
Support complaint analyses, failure investigations, adverse event reporting, and field actions
Collaborate with complaint handling and data analysis teams for trending and signal detection
Assist in creating post market plans and reports, and communicate findings to leadership
Support regulatory reporting and respond to authorities’ requests
Participate in CAPA investigations and audits
Qualifications
Bachelor's degree in Biology, Chemistry, or related field
5+ years in medical device, IVD, or pharmaceutical industry
Expertise in Quality Systems, Engineering, Assurance, and Metrics
Strong collaboration and communication skills
Knowledge of FDA QSR, GMP, ISO 13485:2016, ISO 14971, MDSAP, and EU-IVDR is a plus
Experience with PMS, IVD/MD Vigilance reporting, and regulatory audits is a plus
Salary ranges vary by location, with benefits included. Tempus is an equal opportunity employer.
Additional Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Quality Assurance
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Senior Quality Engineer - PMS
role at
Tempus AI
Recent advancements in technology have enabled AI to impact clinical care significantly. Tempus' platform connects real-world evidence to deliver real-time insights to physicians, aiding in selecting appropriate treatments for patients.
We seek a Senior Quality Engineer – PMS with expertise in FDA Quality System Regulation (21 CFR 820), ISO 13485, and experience with CAP/CLIA and New York State regulations, especially in laboratory-developed tests (LDTs). The role involves supporting quality metrics, resolving non-conformances, leading Post-Market Surveillance activities, and ensuring compliance across global markets.
Responsibilities
Assist in Quality Data trending and monitoring within QA
Develop reporting strategies and metrics for Quality Management Review
Implement metric reporting across operations
Lead Major incident management and cross-functional resolution
Support Post Market Surveillance procedures and processes
Trend control limits and assay quality data with Operations
Lead international product risk management activities
Support complaint analyses, failure investigations, adverse event reporting, and field actions
Collaborate with complaint handling and data analysis teams for trending and signal detection
Assist in creating post market plans and reports, and communicate findings to leadership
Support regulatory reporting and respond to authorities’ requests
Participate in CAPA investigations and audits
Qualifications
Bachelor's degree in Biology, Chemistry, or related field
5+ years in medical device, IVD, or pharmaceutical industry
Expertise in Quality Systems, Engineering, Assurance, and Metrics
Strong collaboration and communication skills
Knowledge of FDA QSR, GMP, ISO 13485:2016, ISO 14971, MDSAP, and EU-IVDR is a plus
Experience with PMS, IVD/MD Vigilance reporting, and regulatory audits is a plus
Salary ranges vary by location, with benefits included. Tempus is an equal opportunity employer.
Additional Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Quality Assurance
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