Complaints Handler

Skills, experience, and other compensable factors will be taken into account when determining pay rate. The pay range provided in this posting is a reflection of a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range.

Duration : 3 months - possible extension

Job Summary :

The Complaint Handler is responsible for managing and processing customer complaints related to the company’s medical devices. This role ensures that complaints are addressed in compliance with regulatory standards and company policies, while maintaining a focus on patient safety and product quality.

Looking for a minimum of 5 years of complaint experience.

Key Responsibilities :

• Receive, document, and assess customer complaints about medical devices.
• Investigate and resolve complaints in accordance with regulatory requirements and company procedures.
• Work closely with the quality assurance, regulatory, and customer service teams to ensure timely and accurate complaint resolution.
• Ensure all complaints are recorded accurately in the company’s complaint management system. (They use ETQ but you do not have to be proficient in it)
• Ensure that complaint investigations are thorough and compliant with relevant regulations (e.g., FDA, ISO).
• CAPA experience is not needed but would be a plus .
• Prepare and submit reports related to complaint handling for management and regulatory bodies.
• Identify trends in complaints and provide feedback to the quality and product development teams for continuous improvement.

Qualifications :

• Strong communication and problem-solving skills.
• Knowledge of medical device industry regulations and standards (e.g., FDA, ISO 13485).
• Experience in complaint handling, quality assurance, or customer service is preferred.
• Detail-oriented and able to work independently.