Complaint Analyst USA
Role Overview
The Complaint Analyst handles complaint data from Field Representatives and Customers by entering it into the quality system, conducting follow-ups, and managing complaints through to closure with a final review. This mid-level role involves facilitating investigations, ensuring compliance with FDA regulations, and collaborating with Engineering and Quality teams in a fast-paced environment. The hire will impact post-market compliance and product quality by maintaining thorough documentation and driving investigations to timely completion.
Perks & Benefits
The role is likely remote-friendly, given the job board context, with expectations to work in USA time zones, possibly PST due to the company's headquarters in Pleasanton, California. It offers a dynamic, fun, and diverse team atmosphere, with opportunities for career growth in a medical device startup environment focused on innovation in urology. Benefits may include standard remote work support, though specifics are not detailed, and the culture emphasizes high achievement and collaboration.
Full Job Description
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 tiPlease mention the word **INDULGENT** and tag RMTY3LjIzNS4xMy4xNg== when applying to show you read the job post completely (#RMTY3LjIzNS4xMy4xNg==). This is a beta feature to avoid spam applicants. Companies can search these words to find applicants that read this and see they're human.