Senior Quality Engineer II at Tempus

Chicago, Illinois, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Biotechnology, Medical DevicesIndustries

Requirements

5+ years of experience in the Medical Device/Pharmaceutical regulated industry
BS degree in Engineering field such as Biomedical, Bioengineering or Chemical Engineering
Experience with applicable FDA, European and other relevant clinical/regulatory requirements, international standards, including ISO 13485, ISO 14971, EU IVDR/MDR and 21 CFR 820
Experience in managing FDA or EU pre-market development and post-market surveillance activities
Experience working in a fast-paced project core-team environment
Excellent oral and written communication skills and can communicate at multiple levels in the organization
Proficient in Microsoft Office (Word, PowerPoint, Excel, etc.)
Proficient in eQMS systems (Jama, ComplianceQuest, Pilgrim SmartSolve, etc.)
This position is onsite in Illinois

Responsibilities

Responsible for implementation of quality assurance principles and practices for design, development, manufacturing, and lifecycle management of Tempus’ assay products, including medical devices and lab developed tests (LDTs)
Responsible for core team oversight of Class 3 US FDA and Class C EU IVDR compliance, including pre-market development and post-market surveillance activities, across multiple devices
Responsible for coordinating cross-functional efforts for the creation and maintenance of DHF and IVDR Technical Documentation across devices
Ensure the relevance, adequacy, and effectiveness of Tempus’ QMS and its continuous improvement with a proactive and preventive risk-based approach
Implement risk management principles per ISO 14971
Maintain and execute change management process, ensuring change impact and action items are appropriately evaluated, tested and documented
Apply medical device quality system knowledge as part of quality leadership, including but not limited to audits, nonconformances, CAPAs, supplier qualification, etc
Participate in internal and external quality system audits as required
Participate in root cause investigations as quality events/incidents arise
Share knowledge and expertise with teammates
Support other duties as assigned

Skills

Quality Assurance

ISO 14971

Risk Management

FDA Compliance

IVDR

QMS

DHF

Change Management

Post-Market Surveillance

Medical Devices

LDT

Tempus

AI-driven healthcare data analysis platform

About Tempus

Tempus focuses on enhancing patient outcomes through the use of data and artificial intelligence in healthcare. The company offers a platform that analyzes medical data to provide insights for physicians, helping them make better treatment decisions. This platform also aids pharmaceutical and biotech companies in drug development by identifying new targets and assessing treatment effectiveness. For patients, Tempus identifies personalized therapy options, particularly in cancer care, where their research has shown increased opportunities for tailored treatments. They have developed a pan-cancer organoid platform and a liquid biopsy assay for profiling circulating tumor DNA. Tempus generates revenue by charging healthcare providers and companies for access to their platform and insights, setting them apart from competitors by their focus on personalized medicine and extensive cancer research.

Chicago, IllinoisHeadquarters

2015Year Founded

$894.9MTotal Funding

IPOCompany Stage

AI & Machine Learning, Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Relocation Assistance

Company Equity

Performance Bonus

Risks

Competition from partners like Genialis may lead to conflicts of interest.

Ambry Genetics acquisition could pose financial risks if synergies aren't realized.

Technical challenges may arise in integration with Flatiron's OncoEMR platform.

Differentiation

Tempus uses AI to analyze clinical and molecular data for precision medicine.

Their platform aids in personalized treatment decisions for cancer patients.

Tempus collaborates with biotech firms to enhance drug development using real-world data.

Upsides

Increased AI adoption in healthcare boosts Tempus' partnerships and collaborations.

Acquisition of Ambry Genetics expands Tempus' genetic testing capabilities.

Integration with Flatiron's OncoEMR enhances precision in cancer treatment plans.

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