Quality Engineer
Description For Quality Engineer
Tempus is revolutionizing healthcare through its proprietary AI-powered platform that connects real-world evidence to deliver actionable insights to physicians. As a Quality Engineer, you'll join a multidisciplinary team working on In Vitro Diagnostics (IVD) medical devices and Laboratory Developed Test (LDT) products. This role combines hands-on experience with quality assurance, risk management, and product development throughout the entire lifecycle of regulated products.
You'll be responsible for implementing quality assurance principles, managing product risks, reviewing documentation, and participating in various quality-related activities including audits and investigations. The position requires expertise in regulatory requirements and quality standards such as ISO 9001, ISO 13485, and FDA regulations.
This is an excellent opportunity for someone passionate about precision medicine and healthcare advancement. You'll work in a fast-paced environment where your contributions directly impact the development of medical devices and diagnostic products. The role offers the chance to work with cutting-edge technology while ensuring compliance with critical quality standards.
The ideal candidate brings a strong background in medical device or pharmaceutical industry, with experience in quality systems and regulatory requirements. You'll need excellent communication skills to work effectively across multiple organizational levels and strong analytical abilities to handle technical data effectively.
Join Tempus in its mission to transform healthcare through technology and make a meaningful impact on patient care. The company offers a collaborative environment and the opportunity to work on innovative solutions that are changing the healthcare landscape.
Responsibilities For Quality Engineer
- Implement quality assurance principles for design and maintenance of Tempus' assay products and manufacturing processes
- Manage product risk management activities during initial product realization and changes
- Review quality assurance for correctness of Tempus documents and records
- Participate in project DHF and DMR documentation development
- Participate in internal and external quality system audits
- Conduct root cause investigations for quality events/incidents
- Participate in design transfer and process validation activities
- Coordinate quality metrics and indicators monitoring
- Coordinate change management process
- Ensure change impact and action items are properly evaluated and documented
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)
- Analytical skills and ability to understand technical data
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