DTx Quality Engineer (6 Month Contract)

DTx Quality Engineer (6 Month Contract) at Click Therapeutics, Inc. responsible for initiating and managing complaint records, maintaining audit readiness, and coordinating with cross-functional teams to determine root cause of issues.

Requirements

• Initiate and manage complaint records for investigational and commercial SaMD applications
• Maintain all records in a state of audit readiness
• Evaluate incoming complaint information on whether reporting to applicable government agencies is required
• Coordinate with cross-functional teams to gather investigation information and determine root cause of issues
• Perform trend analysis on complaints and evaluate whether complaints result in a new or changed risk
• Coordinate quality aspects of release management
• Support the creation of release documentation
• Maintain the log of known software anomalies
• Ensure the products’ Design & Development Files are maintained and updated in compliance with applicable regulations and standards
• Assist product risk management activities
• Lead interdisciplinary design reviews at product development milestones

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship