Manager, Complaint Analyst - Remote, USA

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 Manager is responsible for planning, assigning, and leading the team responsible for the complaint intake , follow ups, and final complaint review , investigation, analysis, resolution, and trending of complaints . This includes ensuring the timely processing of complaints and adverse event reporting .

The Product Monitoring Manager works with cross - functional groups such as Investigators, Medical Affairs, Regulatory, Operations, Customer Service and R D to perform all aspects of handling . In This Role, You Will : Manage high-performing Analysts by recruiting, selecting, orientating, and developing team member growth. Lead and motivate a high-performing team by communicating job expectations, developing action plans, monitoring and appraising work performance, coaching and counseling team members.

Complete c heck- i ns and a nnual p erformance r eviews . Manage, create and update goals for direct reports. Participate and lead Propel Validations and updates Create and update complaint documentation and procedures.

Train new team members on proper complaint intake, follow ups, reviews, and closures . Train team members on new processes . Recommend and implement changes in complaint processes.

Review the accuracy of team member complaints and communicate changes as needed. Participate in Quality team audits as the complaint intake SME. Facilitate complaint investigations while ensuring completeness and consistency of complaint files/records, and participate in generating reports for complaint data, metrics and trends.

Support all post market compliance activities including handling of customer complaints and medical device reporting in accordance with 21 CFR Part 803 Medical Device Reporting. 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.

Review Literature and Articles submitted by other departments to identify potential complaints.

Requirements

Coordinate complaint investigation efforts with Quality and R D team driving investigations to completion in a timely manner. Prepare and present metrics related to the Complaint Handling process including complaint timeliness, as reported and as investigated events, and medical device reporting. Collaborate with Customer Service, Regulatory, R D, Manufacturing, Commercial and other functional areas to obtain/provide information related to complaint investigations and other aspects of complaint handling.

Assist in updating Quality procedures as required through the change order process. Maintain comprehensive records of customer interactions, complaints, and resolutions in the company's electronic Quality Management System. Perform other duties as assigned by Quality Management.

Who You Will Report To: Sr.

: Education : Bachelor of Science in Engineering, Technical or Life Science dis cipline; or equivalent work experience preferred Minimum 1 5 years of experience working in the medical device industry Work location: Remote (within California) Travel : Ability to travel up to 10% .