Lead Quality Engineer

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
• Illinois Pay Range : $110,000-$155,000
• NY/CA Pay Range: $120,000-$165,000
• We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual or

Benefits

Additional Information

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. The Lead Quality Engineer will work in a multidisciplinary team of subject-matter-experts in the development and sustaining of Tempus' In Vitro Diagnostics (IVD) medical devices and Laboratory Developed Test (LDT) products. This is a hands-on role where the Lead Quality Engineer will apply diversified knowledge mainly in the areas of product development, risk management, and post-market surveillance, as well as overall and quality principles and practices throughout the entire lifecycle of Tempus' regulated products. Responsibilities include the following: 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 (PMS) activities, across multiple devices. Responsible for ownership of the EU PMS framework and related deliverables, specifically PMS plans, periodic safety update reports, post-market performance follow up plans and reports, and other required activities and documentation. Responsible for identifying PMS trends for Management Review. Responsible for coordinating cross-functional efforts for the creation and maintenance of DHF and IVDR Technical Documentation across devices. Responsible for investigational device development, clinical performance, and lifecycle management according to US FDA and EU IVDR requirements. 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, including consideration of EU PMS risks. 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

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