Job Title: Customer Quality and Complaint Specialist

Work Location: Middlesex County, New Jersey

Summary:

This role is responsible for managing customer service operations, complaint handling, and vendor management to ensure high-quality support and compliance with regulatory standards. The position collaborates with cross-functional teams to enhance customer satisfaction and post-market quality processes.

Responsibilities:

• Act as the main contact for daily customer service activities, ensuring prompt and professional support for all customer inquiries and issues.
• Coordinate with third-party vendors and maintain service level agreements to ensure consistent customer service delivery.
• Document, process, and manage customer complaints in compliance with regulatory requirements and internal procedures.
• Collaborate with internal teams to investigate complaints, analyze trends, and identify opportunities for quality improvement.
• Monitor and report on customer service and complaint handling metrics, preparing regular updates for management.
• Oversee communication and performance reviews with outsourced vendors, ensuring adherence to approved procedures and training requirements.
• Support regulatory and quality activities, including audit preparation, CAPA participation, and maintenance of complaint handling documentation.
• Continuously seek and implement improvements in customer service, complaint handling, and regulatory compliance processes.

Qualifications:

• Bachelor's degree in Business Administration, Life Sciences, Healthcare, Engineering, Quality, or a related field.
• 3-5 years of experience in customer service, customer support, or customer relationship management, preferably in a regulated industry such as healthcare.
• Experience handling customer inquiries, issue resolution, and communication with both internal and external stakeholders.
• Experience coordinating with external service providers or customer service vendors.
• Experience with medical device complaint handling, customer quality, or Quality Management System (QMS) processes is preferred.
• Familiarity with FDA Quality System requirements, ISO 13485, CAPA, or post-market surveillance is a plus.
• Experience using CRM, complaint management, or QMS software is desirable.
• Excellent customer service, communication, and interpersonal skills.
• Strong organizational, analytical, and problem-solving abilities with attention to detail.
• Ability to manage multiple priorities and work effectively in a cross-functional environment.
• Proficiency in Microsoft Office; knowledge of electronic QMS/CRM systems is a plus.

Published Category: Quality & Validation