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.

We are looking for a Senior Manager, Quality Engineering that has experience in the areas of FDA QSR (21 CFR 820), ISO 13485, ISO14971, IVDD/IVDR, as well as CLIA, CAP, NYSDOH. This role will support product quality during clinical studies and from launch to End of Life. Responsibilities include oversight of all postmarket surveillance (PMS) activities including complaint intake and record processing, failure investigations, adverse event reporting, complaint trending and signal detection, product concerns, and “field” action activities. This individual is also responsible for postmarket or operational activities, including drafting plans and reports as well as the communication of postmarket information with leaders throughout the organization to drive action and align decisions. The Senior Manager, Quality Engineering will also participate in risk management activities, associated with postmarket activities and lifecycle management..

Responsibilities:

Key Contribution: Improvements to the PMS framework in accordance to the FDA QSR, ISO 13485, and IVDR, as well as the collection and analysis of data to support postmarket surveillance activities and execution of appropriate field actions when relevant.

• Create and maintain all postmarket procedures and processes related to planning, reporting and monitoring of Tempus applicable products.
• Own the tracking, trending and regulatory reporting of global adverse events for medical devices . Ensure timeliness and accuracy of regulatory reporting.
• Support the trending of QMS data to secure product improvements, which includes (but not limited to); Complaints , CAPA/SCAR, Corrections/ Recalls, NCR, Deviations,etc.
• Establish and maintain Periodic Safety Update Reports (PSUR) and postmarket Surveillance (PMS) reports
• This position will also assist in maintaining and developing existing PMS/PMPF processes and procedures.
• Provide training and guidance on the complaint handling process to the Organization.
• Responsible for presenting product lifecycle metrics, trends and issue escalation.
• Responsible for collaborating with Regulatory on the Medical Device Reporting process, and leading recalls, corrections, and removal activities as required
• Ensure product launch requirements include appropriate postmarket surveillance assigned during commercial launch planning
• Execute postmarket surveillance plans in the commercial lifecycle including periodic review and reporting requirements.
• Leads all aspects of complaint management process, including management of Investigations/Failure Analysis
• Coordinates cross functional teams required for complex complaint investigations, quality issue escalations
• Reviews the reportability of complaint data and calls out possible safety issues, as applicable
• Prepares and presents data for periodic Quality Management Review
• Maintain device product repository for the quality history of device products throughout the product lifecycle.
• Serve as an SME related to postmarket surveillance, Device Risk Management and Adverse Event Reporting.
• Coordinate and advise on customer and product feedback information into various departments such as R&D and Operation.
• As needed, participate on teams to ensure robust application of appropriate controls in the design, development, qualification, commercialization and lifecycle management of Tempus Device products.
• Engages in continuous improvement activities by identifying opportunities and recommending improvements to the design and development process.

Qualifications:

• B.S. degree in Biology, Molecular Biology, BioMedical Eng., Chemistry, Mechanical Eng or a related scientific field. and 8+ years of experience in industry or combined industry and research
• M.S. degree in Biology, Molecular Biology, BioMedical Eng., Chemistry, Mechanical Eng or a related scientific field. and 6+ years of experience in industry or combined industry and research
• 8+ years of quality experience in a FDA/ISO/IVDD/IVDR regulated environment.
• 8+ years of experience in the medical device, diagnostics, or biopharmaceutical industry with direct involvement in postmarket surveillance.

Bonus Points For:

• Subject matter expert in in vitro diagnostic device quality.
• Deep understanding of the Reactive and Proactive indicators utilized to monitor and confirm performance of devices within the lifecycle (including tools and techniques for assessment)
• Skilled oral and written communicator with an ability to identify problems, review related information, develop and evaluate options, and implement solutions
• Experience working in a matrixed organization, leading through influence across stakeholders (Research & Early Development, Product Development, Commercial, and Regulatory and Medical Affairs)
• Expert knowledge of device product regulations/standards
• Knowledge of continuous improvement methodologies and practices Prior experience with regulators including back and front room inspection experience
• Expert knowledge of global device product adverse event reporting requirements
• Experience with the monitoring and analysis of postmarket data including reactive and proactive data sets
• Proficiency in risk analysis tools and techniques (e.g. Hazard Analysis, FMEA, Fault Tree, Pareto diagrams, cause-and-effect diagrams, 5 why’s, etc.)
• Basic statistical methods including trend analysis, Pareto, and other basic charting techniques is preferred
• Demonstrated ability to collaborate and influence in a matrix environment with good oral and written communication skills

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