Quality Engineer

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 ideally have experience in the areas of FDA QSR (21 CFR 820), and ISO 13485. The Quality Engineer should have previous exposure to CAP/CLIA, NYS requirements as the Laboratory develops, validates and performs Lab Developed Test (LDT) assays. The Quality Engineer will participate in the following activities;  material receipt and disposition, record handling and retention, Change Management, non-conformance reporting/issue resolution, root cause analysis, routine QA inspections of the laboratories, and equipment validation and process validation activities.

Schedule: Day Shift - Mon-Fri

RESPONSIBILITIES

• Provide quality assurance support for the laboratory quality control activities as needed.
• Performs Quality review for correctness and completeness of quality system records; Ensures all required documentation is included in records and that the documentation is accurate
• Responsible for Acceptance Activities including; Dispositions, Incoming Material Specification documentation, SCARs, Final Release, Quarantining, Inventory Control, Reagent/Material review and approval,  in-process QC activities.
• Responsible for performing Product Quarantine/MRB activities, including initiation and release.
• Support the Change Management process, including reviewing and approving change controls for process and/or product. Ensure Change implementation and follow-up for effectiveness of change.
• Participate in Non-conformance event reporting for non-conforming products, including device and/or incoming materials and reagents.
• Participate as needed in laboratory issue management activities requiring quality assurance approval and investigative support
• Participates in Internal and External Quality System Audits as required.
• Participate in Quality Event investigations and root cause analysis as required.  

• Participate in Design Transfer and Process Validation activities associated with new product development
• Assist in DHR and DMR creation for products. 
• Work with R&D and Laboratory Operations personnel to ensure compliance to product and process control standards as required by FDA 820.70.
• Collaborate with R&D and Lab Operations personnel on Process Failure Mode Analysis (pFMEA), as needed.
• Lead and/or support other duties as assigned.

Qualifications 

• 2+ years of experience in the Medical Device/Pharmaceutical regulated industry, preferably in a quality assurance or quality control role.
• Bachelor's Degree in science field is preferred
• Demonstrate working knowledge laboratory validation experience 
• Experience with statistical analysis and application of statistical methods.
• Excellent oral and written communication, organizational, and skills are required.
• Proficient in MicroSoft Office (Word, PowerPoint, Excel, etc.).
• Ability to work through complex issues and differences in a creative, constructive, and diplomatic manner.
• Ability to manage multiple tasks with limited supervision.
• Prioritize numerous activities in a rapid paced environment
• Contribute to team-oriented tasks
• Analytical skills and ability to understand technical data
• Decision-making skills