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 Operations Quality Engineer will have experience in the areas of FDA QSR (21 CFR 820), and ISO 13485. The Operations Quality Engineer will support medical device/IVD quality through design transfer, process validations, product launch and post launch activities as part of a cross-functional team. The Operations Quality Engineer will also participate in activities involving product impact assessments, change controls, product quarantine activities, non-conformance reporting/issue resolution, root cause analysis, routine QA inspections of the laboratories, and QA approval of facility and equipment maintenance and validations. This individual also ensures compliance to CAP/CLIA, NYS requirements as the Laboratory develops, validates and performs Lab Developed Test (LDT) assays.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Participate in Design Transfer and Process Validation activities associated with new product development
- Creates/reviews Protocols, Process and Product Validations, and Test Methods.
- Responsible for Assisting 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).
- Responsible for incoming/receiving, in-process, and finished device acceptance activities such as incoming material inspection release, in-process QC activities, and final product release.
- Responsible for performing Product Quarantine/MRB activities, including initiation and release.
- Performs Quality review for correctness and completeness on assigned in-process documentation to support QA release decisions/activities, including DHR/batch-record review.
- Ensures all required documentation is included in records and that the documentation is accurate.
- Utilizes the Change Control process where required, including initiating, reviewing and approving change controls for process and/or product.
- Provide direction, guidance and support for Installation, Operational and Performance Qualification (IQ/OQ/PQ) Protocols for various manufacturing equipment, and facility and environment control monitoring programs.
- Provide quality support for the Equipment Calibrations and Maintenance.
- Creates and reviews Quality System Documentation for production and release activities .
- Participate in contract manufacturing onboarding processes.
- Participate in product and process investigations (CAPA, Audit responses, nonconformances, etc.)
- Support Post Market Surveillance Program by reviewing complaints, initiating corrective actions, participating in investigations, etc.
- Provides support for the Quality Department as required for general quality assurance activities such as Training, Document Control, Audit Backroom support, Non-conformances, change control, process improvement and implementations.
- Participates in Internal and External Quality System Audits.
- Analyze audit results for trends and provide feedback to QA Ops Management and QA team.
- Interact with Quality, Engineering, Supply Chain and Laboratory personnel to provide support for quality objectives and process improvement efforts within operations
- Lead and/or support other duties as assigned.
Schedule: Day Shift - Mon-Fri
Education: Bachelor's Degree
- 3-5 years of experience in Medical Device/Pharmaceutical regulated industry in a quality assurance or quality control role.
- Demonstrate working knowledge of Facilities Validation, Equipment Validation, Process Validation, Computer Validation, and Operational Excellence.
- Strong experience in FMEAs, Lean/Six Sigma projects, process capability, statistical analysis and application of statistical methods.
- Excellent oral and written communication, organizational, and teamwork 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.