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 Manageris 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 check-ins and annual performance reviews. • 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 propercomplaint 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. • 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 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. Manager, Product Monitoring Requirements: • Education: Bachelor of Science in Engineering, Technical or Life Science discipline; or equivalent work experience preferred • Minimum15yearsof experience working in the medical device industry • Work location: Remote(within California) • Travel: Ability to travel up to 10%. Overnight domestic and/or international travel may be required • Working knowledge of FDA 21 CFR part 820.198 and part 803, ISO 13485 and related ISO/EN standards. • Strategic yet hands-on when needed with a high degree of energy and drive, and the ability to seek function and process improvements continually. • Open and direct communication style and a vision for continuous improvement and excellence. • Experience with Class II and/or III sterile devices (preferred). • Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally. • Compliance with relevant county, state, and Federal rules regarding vaccinations. What We Offer: At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team. You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture. ...