Senior Supplier Quality Assurance Specialist

3 weeks ago

Durham, United States Tempus Full time
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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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.

Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote roles- Tempus reasonably believes that criminal history may have a direct, adverse and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: engaging positively with customers and other employees; accessing confidential information, including intellectual property, trade secrets, and protected health information; and appropriately handling such information in accordance with legal and ethical standards. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

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