Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.
Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere.
Summary:
The Complaint Analyst receives complaint data from Field Representatives and Customers, enters the information into the quality system, follows up with the Field Rep or Customer to gather more information, owns and tracks a complaint through the process, and completes a final review of complaints to verify completeness before closure. This position requires experience with FDA Quality Management System Regulations and the ability to perform at high levels in a high-paced, dynamic environment.
In This Role, You Will:
- Facilitate complaint investigations while ensuring completeness and consistency of complaint files/records.
- Support post-market compliance activities including handling of customer complaints in accordance with documented procedures
- Evaluate complaints and perform preliminary complaint investigation including follow up with healthcare professionals and sales representatives
- Escalate complaints when encountering new failure modes, and partner with Engineering, Field Personnel, and Quality Assurance to investigate.
- Ensure complaint documentation and records are complete in compliance with regulatory requirements
- Coordinate complaint investigation efforts with Quality and R&D team driving investigations to completion in a ti
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