Manager, Complaint Analyst

Calyxo, Inc.

Manager of Complaint Analysts leading a team in complaint resolution for a medical device company. Working remotely while ensuring compliance and quality in complaint handling processes.

Posted 7/17/2026full-timeRemote • California • 🇺🇸 United StatesSeniorLead💰 $145,000 - $155,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing high-performing teams within the medical device industry, focusing on complaint management, regulatory compliance, and continuous process improvement. Possesses strong communication skills and a strategic mindset to drive team development and operational excellence.

Highest-signal resume keywords

Team ManagementComplaint Process ImprovementFDA 21 CFR ComplianceMedical Device Industry ExperienceTraining and Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Complaint DocumentationPerformance ReviewsQuality AuditsComplaint InvestigationData AnalysisISO 13485 KnowledgeRegulatory ComplianceProcess ImprovementMetrics ReportingClass II/III Device Experience

Soft Skills

Open CommunicationCoachingMotivationTeam DevelopmentStrategic Thinking

Industry Keywords

Medical Device IndustryFDA RegulationsISO StandardsComplaint ManagementSterile Devices

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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