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 Principal 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 Principal Quality Engineer will apply diversified knowledge in the areas of product development, risk management 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 and maintenance of Tempus’ assay products and manufacturing processes through the entire product lifecycle
- Responsible for product risk management activities during initial product realization and during product changes, pre- and post-launch
- Analyze and review data for product verification and validation
- Ensure the relevance, adequacy and effectiveness of Tempus QMS and its continuous improvement with a proactive and preventive risk-based approach.
- Maintain and execute change management process, ensuring change impact and action items are appropriately evaluated, tested and documented
- Coordinate the planning and development of project DHF and DMR documentation
- 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
Qualifications
- 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 CAP/CLIA, ISO 9001, ISO 13485, ISO 14971, EU IVDR/MDR and 21 CFR 820, etc.
- 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, ETQ, Pilgrim SmartSolve, etc.)
- Analytical skills and ability to understand technical data
- This position is onsite
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