Quality Engineer
Description For Quality Engineer
Tempus is at the forefront of revolutionizing healthcare through AI and precision medicine. As a company that has developed a proprietary platform connecting real-world evidence to deliver real-time, actionable insights to physicians, Tempus is making significant strides in ensuring patients receive the right treatments at the right time.
The Quality Engineer role presents an exciting opportunity to work with cutting-edge medical technology in a multidisciplinary environment. You'll be directly involved with In Vitro Diagnostics (IVD) medical devices and Laboratory Developed Test (LDT) products, applying your expertise in quality assurance and risk management throughout the product lifecycle.
This position offers a competitive salary range of $75,000 to $100,000 USD for Illinois-based candidates, along with comprehensive benefits. The role combines technical expertise with quality management, requiring someone who can navigate complex regulatory requirements while maintaining high standards of product quality and safety.
You'll be working in a hybrid environment, collaborating with subject-matter experts and contributing to various aspects of quality assurance, from document review to process validation. The ideal candidate will bring at least 2 years of experience in the Medical Device/Pharmaceutical regulated industry, along with a strong understanding of FDA and European regulatory requirements.
This is an excellent opportunity for a quality-focused professional who wants to make a meaningful impact in healthcare technology. You'll be part of a company that's actively shaping the future of precision medicine, while working with state-of-the-art technology and contributing to products that directly impact patient care.
The role offers significant growth potential and the chance to work with various quality management systems and tools. Your work will be crucial in ensuring Tempus' products meet the highest standards of quality and regulatory compliance, ultimately contributing to better patient outcomes through advanced healthcare technology.
Responsibilities For Quality Engineer
- Implementation of quality assurance principles for design and maintenance of assay products and manufacturing processes
- Product risk management activities during initial product realization and changes
- Quality assurance review of Tempus documents and records
- Planning and development of project DHF and DMR documentation
- Participation in internal and external quality system audits
- Root cause investigations for quality events/incidents
- Design transfer and process validation activities
- Coordination of quality metrics and indicators
- Management of change process and impact evaluation
Requirements For Quality Engineer
- 2+ years of experience in Medical Device/Pharmaceutical regulated industry
- BS degree in Engineering (Biomedical, Bioengineering or Chemical Engineering)
- Experience with FDA, European and clinical/regulatory requirements
- Knowledge of ISO 9001, ISO 13485, ISO 14971, EU IVDR/MDR and 21 CFR 820
- Experience in fast-paced project core-team environment
- Excellent oral and written communication skills
- Proficient in Microsoft Office
- Proficient in eQMS systems (Jama, ETQ, Pilgrim SmartSolve)
- Strong analytical skills and ability to understand technical data
Benefits For Quality Engineer
- Medical Insurance
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