Manager, Complaint Analyst

Job not on LinkedIn

🕒 July 17

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Logo of Calyxo, Inc.

Calyxo, Inc.

11 - 50 employees

Founded 2016

🏥 Healthcare

💼 Consulting

⚕️ Healthcare Insurance

Healthcare • Consulting • Healthcare Insurance

Calyxo, Inc. is a company focused on revolutionizing kidney stone care through innovative medical technology. Their flagship product, the CVAC System, is designed to efficiently clear kidney stones using a minimally invasive procedure called the SURE Procedure. This procedure integrates ureteroscopy, laser lithotripsy, microjet irrigation, dynamic aspiration, and stone collection to provide superior stone clearance rates compared to traditional methods. Backed by clinical evidence, Calyxo, Inc. aims to set a new standard in the management of kidney stone patients.

📋 Description

• 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 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.

🎯 Requirements

• Education: Bachelor of Science in Engineering, Technical or Life Science discipline; or equivalent work experience preferred • Minimum 15 years of 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.

🏖️ Benefits

• Competitive base salary range of $145,000- $155,000 • Stock options – ownership and a stake in growing a mission-driven company • Employee benefits package that includes 401(k), healthcare insurance and paid vacation

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