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 ideal candidate for Quality Engineer, Complaints plays a vital role in ensuring the highest standards of product quality and compliance.The Quality Engineer, Complaints will have experience in the areas of FDA QSR (21 CFR 820), ISO 13485, ISO14971, IVDD/IVDR.  This role will support complaint handling and post market surveillance activities.  Responsibilities include complaint intake and record processing, failure investigations, adverse event reporting, complaint trending, and “field” action activities. The Quality Engineer, Complaints will also participate in risk management activities associated with postmarket activities and lifecycle management..   

Responsibilities will include:

• Evaluate customer complaints and feedback in accordance with quality and regulatory requirements, including determination of reportability. 
• Assesses complaint information provided, gather any missing information for complaint file, and escalates complaint to appropriate parties as needed.
• Support all aspects of complaint management process, including management of Investigations/Failure Analysis 
• Lead investigation activities for complaints and document all activities
• Collaborate with customer success and sales teams to investigate complaints. 
• 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
• Contribute to data collection and statistics for products
• Facilitate investigations for nonconforming product, corrective and preventive action (CAPA), and other quality events by coordinating inputs from various departments.
• Ensure timeliness and accuracy of regulatory reporting.
• Contribute to Periodic Safety Update Reports (PSUR) and postmarket Surveillance (PMS) reports
• Provide training and guidance on the complaint handling process to the Organization.
• Collaborate with Regulatory on the Medical Device Reporting, recalls, corrections, and removal activities as required
• Prepare data for periodic Quality Management Review
• Performs other related duties and projects as required at direction of management.

QUALIFICATIONS:

• B.S.  degree in Biology, Molecular Biology, BioMedical Eng., Chemistry, Mechanical Eng or a related scientific field. and 2+ 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 1+ years of experience in industry or combined industry and research.
• 2+ years of quality experience in a FDA/ISO/IVDD/IVDR regulated environment.
• 2+ years of experience in the medical device, diagnostics, or biopharmaceutical industry with direct involvement in postmarket surveillance.

PREFERRED QUALIFICATIONS:

• Skilled oral and written communicator with an ability to identify problems, review related information, develop and evaluate options, and implement solutions.
• Knowledge of device product regulations/standards.
• Knowledge of continuous improvement methodologies and practices. 
• Knowledge of global device product adverse event reporting requirements. 
• Experience with the monitoring and analysis of postmarket data.
• 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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