Complaint Analyst

Jobgether

13h • $94,000 - $110,000 • Remote

About The Position

This role offers a pivotal opportunity for a detail-oriented professional to manage and investigate customer complaints in a highly regulated, fast-paced environment. The Complaint Analyst will oversee the full lifecycle of complaints, ensuring thorough documentation, regulatory compliance, and timely resolution. You will work closely with cross-functional teams—including Quality, R&D, Customer Service, and Field Representatives—to identify trends, escalate issues, and support post-market surveillance. This role requires strong analytical skills, excellent communication, and a proactive approach to process improvement. Remote work flexibility allows for a dynamic work environment while maintaining close collaboration with stakeholders. Your efforts will directly contribute to product quality, customer satisfaction, and organizational compliance.

Requirements

• Bachelor’s degree in Engineering, Technical, or Life Science discipline, or equivalent work experience.
• Minimum 5 years of experience in the medical device industry.
• Strong knowledge of FDA regulations, ISO 13485, and relevant ISO/EN standards.
• Excellent verbal and written communication skills, with a professional and clear communication style.
• Ability to perform strategically and hands-on, with a focus on continuous improvement and process optimization.
• Willingness to travel up to 10%, including potential overnight domestic or international trips.

Nice To Haves

• Experience with Class II and/or III sterile devices preferred.

Responsibilities

• Receive, document, and track complaints from customers and field representatives in the quality management system.
• Conduct preliminary complaint investigations, including follow-up with healthcare professionals and sales personnel.
• Facilitate complaint investigations, ensuring consistency, completeness, and compliance with regulatory requirements.
• Collaborate with Engineering, R&D, Manufacturing, Regulatory, and Customer Service teams to resolve complaints efficiently.
• Escalate new failure modes and participate in post-market compliance activities as required.
• Maintain accurate and comprehensive records of complaints, interactions, and resolutions.
• Support internal and external audits and assist in updating quality procedures as needed.

Benefits

• Competitive base salary of $94,000–$110,000 with a variable incentive plan.
• Stock options, providing ownership in a mission-driven company.
• Comprehensive employee benefits, including healthcare, 401(k), and paid vacation.
• Opportunity to work remotely in a dynamic and inclusive environment.
• Exposure to a collaborative, diverse, and high-performing team culture.
• Continuous learning and professional growth opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level