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Quality Engineer

TempusChicago, Illinois, United StatesOnsite

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 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 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
  • Responsible for product risk management activities during initial product realization and during product changes, pre- and post-launch
  • Responsible for quality assurance review for correctness and completeness of Tempus documents and records
  • Participate in 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
  • Participate in design transfer and process validation activities
  • Coordinate identification and monitoring of quality metrics and indicators
  • Coordinate change management process, ensuring change impact and action items are appropriately evaluated, tested and documented
  • Support other duties as assigned

Qualifications 


  • 2+ 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 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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We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.Additionally, for remote roles open to individuals in unincorporated Los Angeles – including remote roles- Tempus reasonably believes that criminal history may have a direct, adverse and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: engaging positively with customers and other employees; accessing confidential information, including intellectual property, trade secrets, and protected health information; and appropriately handling such information in accordance with legal and ethical standards.

Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

Life at Tempus

Tempus helps corporate clients navigate global currency markets by combining unparalleled market insight, competitive rates of exchange and unmatched personalized service. We serve thousands of corporate clients by offering these key differentiated features:
Thrive Here & What We Value1. Collaborative Mindset: The company culture at Tempus emphasizes teamwork and collaboration, as seen through the Sales Representative's focus on cross-functional relationships to achieve work goals.2. Innovation and Technology: Tempus values innovation in genomic data usage and advanced technology implementation for improving patient care.3. Integrity and Trust: The company upholds integrity, respect, and trust as core values in all interactions with clients and colleagues.4. Commitment to Quality Care: A strong focus on delivering critical information about the right treatments at the right time for patients demonstrates a commitment to quality care.5. Salesforce Effectiveness: The company encourages sales force effectiveness, as seen through the emphasis on driving results and promoting a culture of compliance within the organization.6. Cross-functional Collaboration: Tempus fosters collaboration across various teams, including oncology and neuropsychiatry clinician-facing sales teams.7. Equal Opportunity Employer: The company is committed to providing equal opportunities for all employees regardless of their background or identity.8. Advanced Communication Skills: Tempus values strong communication skills, as demonstrated by the Sales Representative's advanced presentation and business acumen.9. Passion for Precision Medicine: A passionate commitment to advancing precision medicine in healthcare is a key aspect of the company culture at Tempus.10. Real-time Insights Delivery: The focus on delivering real-time, actionable insights to physicians highlights the importance of timely and relevant information sharing within the organization.
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