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