Manager, Complaint Analyst - Remote, USA

22 hours, 1 minute ago
Full-time
Senior
Quality Assurance and Testing
Calyxo

Calyxo

Calyxo is dedicated to enhancing the treatment of kidney stones through its innovative CVAC System, which combines multiple advanced techniques into a single, minimally invasive procedure for effective stone clearance.

Health Care Providers & Services
11-50
Founded 2016
$47M raised

Description

  • Manage and develop a team of complaint analysts, including recruiting, onboarding, coaching, and performance reviews.
  • Lead complaint intake, follow-up, final review, investigation, analysis, resolution, and trending.
  • Ensure timely processing of complaints and adverse event reporting.
  • Create, update, and maintain complaint documentation, procedures, and quality records.
  • Train new and existing team members on complaint handling processes and updates.
  • Review complaint accuracy and escalate issues or new failure modes as needed.
  • Partner with Quality, R&D, Regulatory, Customer Service, Manufacturing, and other cross-functional teams on investigations.
  • Prepare and present complaint metrics, trends, and medical device reporting data.
  • Support post-market compliance activities and FDA/quality system reporting requirements.
  • Participate in quality audits and serve as the complaint intake subject matter expert.

Requirements

  • 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.
  • Remote work location within California.
  • Ability to travel up to 10%, including possible overnight domestic and/or international travel.
  • Working knowledge of FDA 21 CFR Part 820.198 and Part 803, ISO 13485, and related ISO/EN standards.
  • Experience with Class II and/or III sterile devices preferred.
  • Excellent verbal and written communication skills with the ability to communicate clearly and professionally.
  • Legal authorization to work in the United States is required.
  • Compliance with relevant county, state, and federal vaccination rules.

Benefits

  • Competitive base salary range of $145,000 to $155,000.
  • Stock options.
  • 401(k) retirement plan.
  • Healthcare insurance.
  • Paid vacation.
  • Opportunity to work in a diverse, high-achieving, and experienced team.
  • Opportunity to shape company culture and grow through constant learning and dynamic challenges.

Interested in this position?

Apply directly on the company website

Apply Now

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