Tempus AI Inc.
Senior Supplier 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.
We are looking for a
Senior Supplier Quality Assurance Specialist
who will play an integral role in supporting quality activities related to Supplier Quality Management (SQM) in accordance with the FDA Quality System Regulation, ISO 13485, and other medical device/IVDR regulations. This individual also supports various QMS activities that comply with the FDA QSR, ISO 13485, as well as CLIA/CAP requirements for the clinical laboratories.
Responsibilities include the following:
Support the vendor approval process and implement program updates:
Maintaining supplier controls
Ensure supplier performance meets current expectations, and improve supplier performance and productivity
Maintain Approved Supplier List
Manage Vendor Documentation and Compliance:
Proactively work with suppliers to ensure documentation on file is up to date
Review documents received and escalate any concerns for further review
Review and escalate customer and supplier notifications
Send and Review Supplier Questionnaires
Maintain supplier certificates
SCAR/Corrective Actions:
Maintain SCAR Log
Follow up on action items to ensure completion
Responsible for leading required supplier corrective action activities resulting from non-conforming parts and supplier audits
Supplier Performance Monitoring:
Monitor supplier quality performance metrics, inclusive of product yield and scar response rates.
Provide necessary supplier feedback to drive supplier performance improvement.
Produce supplier metrics to support customer and business reviews.
Support other duties as assigned
Qualifications:
Bachelor’s Degree in Engineering or Science field preferred.
Minimum of 3+ years of experience in a quality engineering/assurance role in the medical device industry.
Working knowledge in all aspects of supplier quality, including supplier assessments/audits, maintaining supplier evaluation program, supplier corrective actions, and supplier process changes.
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).
Strong communication (written and verbal), influencing, negotiating and collaboration skills.
Ability to demonstrate leadership in helping improve quality processes and create efficiencies for business needs.
Demonstrate strong organizational skills including ability to prioritize tasks and adhere to agreed timelines.
Ability to manage and deliver multiple tasks with limited supervision.
Travel may be required up to 10% of the time.
This will be an on-site position.
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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.
We are looking for a
Senior Supplier Quality Assurance Specialist
who will play an integral role in supporting quality activities related to Supplier Quality Management (SQM) in accordance with the FDA Quality System Regulation, ISO 13485, and other medical device/IVDR regulations. This individual also supports various QMS activities that comply with the FDA QSR, ISO 13485, as well as CLIA/CAP requirements for the clinical laboratories.
Responsibilities include the following:
Support the vendor approval process and implement program updates:
Maintaining supplier controls
Ensure supplier performance meets current expectations, and improve supplier performance and productivity
Maintain Approved Supplier List
Manage Vendor Documentation and Compliance:
Proactively work with suppliers to ensure documentation on file is up to date
Review documents received and escalate any concerns for further review
Review and escalate customer and supplier notifications
Send and Review Supplier Questionnaires
Maintain supplier certificates
SCAR/Corrective Actions:
Maintain SCAR Log
Follow up on action items to ensure completion
Responsible for leading required supplier corrective action activities resulting from non-conforming parts and supplier audits
Supplier Performance Monitoring:
Monitor supplier quality performance metrics, inclusive of product yield and scar response rates.
Provide necessary supplier feedback to drive supplier performance improvement.
Produce supplier metrics to support customer and business reviews.
Support other duties as assigned
Qualifications:
Bachelor’s Degree in Engineering or Science field preferred.
Minimum of 3+ years of experience in a quality engineering/assurance role in the medical device industry.
Working knowledge in all aspects of supplier quality, including supplier assessments/audits, maintaining supplier evaluation program, supplier corrective actions, and supplier process changes.
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).
Strong communication (written and verbal), influencing, negotiating and collaboration skills.
Ability to demonstrate leadership in helping improve quality processes and create efficiencies for business needs.
Demonstrate strong organizational skills including ability to prioritize tasks and adhere to agreed timelines.
Ability to manage and deliver multiple tasks with limited supervision.
Travel may be required up to 10% of the time.
This will be an on-site position.
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