Full-Time

Senior Supplier Quality Assurance Specialist

Confirmed live in the last 24 hours

Tempus

Tempus

1,001-5,000 employees

AI-driven healthcare data analysis platform

AI & Machine Learning
Biotechnology
Healthcare

Mid, Senior

Durham, NC, USA

This is an on-site position.

Category
QA & Testing
Quality Assurance
Requirements
  • 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.
Responsibilities
  • 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

Tempus focuses on enhancing patient outcomes through the use of data and artificial intelligence in the healthcare sector. The company offers a platform that analyzes medical data to assist physicians in making informed treatment decisions by providing insights from medical images and identifying care gaps. For pharmaceutical and biotech companies, Tempus aids in drug development by discovering new targets and assessing treatment effectiveness. Patients benefit from personalized therapy options identified through the platform. Tempus conducts significant research, particularly in cancer, and has developed tools like a pan-cancer organoid platform and a liquid biopsy assay for profiling circulating tumor DNA. The company generates revenue by charging healthcare providers and companies for access to its platform and insights, aiming to improve patient care and support drug development.

Company Stage

IPO

Total Funding

$894.9M

Headquarters

Chicago, Illinois

Founded

2015

Growth & Insights
Headcount

6 month growth

5%

1 year growth

15%

2 year growth

36%
Simplify Jobs

Simplify's Take

What believers are saying

  • Tempus's IPO and significant revenue generation indicate strong financial health and growth potential.
  • Collaborations with industry giants like SoftBank and United Therapeutics can lead to groundbreaking advancements and increased market share.
  • The company's focus on personalized therapy and AI-driven insights can significantly improve patient outcomes, making it a rewarding place to work for those passionate about healthcare innovation.

What critics are saying

  • The lawsuit from Guardant Health over patent infringement could result in financial and reputational damage.
  • Operating in a highly competitive market with peers like Foundation Medicine and Guardant Health requires continuous innovation to maintain a competitive edge.

What makes Tempus unique

  • Tempus leverages AI to provide actionable insights from medical data, setting it apart from competitors who may not integrate AI as deeply into their platforms.
  • Their focus on personalized therapy options and extensive cancer research, including a pan-cancer organoid platform and liquid biopsy assay, distinguishes them in the healthcare tech space.
  • Tempus's collaboration with major firms like SoftBank and United Therapeutics highlights its strong industry partnerships and credibility.

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