Calyxo, Inc. · 4 hours ago
Complaint Analyst - Remote, USA
United States
Full-time
Remote
Mid, Senior Level
$94K/yr - $110K/yr
5+ years expCalyxo, Inc. is a medical device company focused on improving kidney stone treatment. The Complaint Analyst will manage complaint data from customers and field representatives, ensuring thorough investigation and compliance with FDA regulations while collaborating with various departments to enhance customer satisfaction.
Health CareMedicalMedical DeviceWellness
No H1B
Responsibilities
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 timely manner
Collaborate with Customer Service, Regulatory, R&D, Manufacturing, Commercial, Medical 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
Support and participate in internal and external audits
Perform other duties as assigned by Quality Management
Qualification
Required
Bachelor of Science in Engineering, Technical or Life Science discipline or equivalent work experience preferred
Minimum 5 years of experience working in the medical device industry
Ability to travel up to 10%. Overnight domestic and/or international travel may be required
Working knowledge of FDA regulation, 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
Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally
Preferred
Experience with Class II and/or III sterile devices
Benefits
Employee benefits package that includes 401(k), healthcare insurance and paid vacation
Stock options – ownership and a stake in growing a mission-driven company
Company
Calyxo, Inc.
Calyxo, Inc.
201-500 employees
Funding
Current Stage
Late StageTotal Funding
$125.44MKey Investors
Avidity Partners
2024-12-26Series Unknown· $28.28M
2023-12-12Series D· $50M
2022-07-06Series C· $32.7M
Leadership Team
Joseph Catanese
President & CEO
Doug Hughes
Chief Financial Officer
Recent News
2025-12-18
2025-10-21
Medical Product Outsourcing
2025-09-13
Company data provided by crunchbase