Complaint Management Specialist II

Location: Franklin Lakes, NJ (Onsite, 5 days/week)
Schedule: Mon Fri, 1st Shift | 40 hrs/week | No OT

The Complaint Management Specialist II is responsible for processing and coordinating customer complaints for medical device products. This role ensures timely documentation, communication, and routing of cases in compliance with regulatory and internal quality standards. The position requires strong communication, data entry accuracy, and the ability to manage inquiries from internal teams and customers.

• Process customer complaints through intake, documentation, tracking, and follow-up

• Enter complaint details and customer information into Excel and internal systems

• Conduct outbound calls to verify receipt of field action notifications and collect required details

• Route calls and cases to proper departments; coordinate resolution and follow-up

• Maintain detailed records of communications, customer interactions, and product details

• Escalate complex or unresolved complaints to management

• Ensure compliance with FDA, ISO, and internal quality policies

• Support customer communications via email, phone, and conference calls

• Perform administrative data management duties and assist as needed

• High school diploma required; Associate degree preferred

• 2+ years of customer service or complaint handling experience preferred

• Strong proficiency in Microsoft Excel and Outlook

• Accurate data entry and documentation skills

• Strong communication and problem-solving abilities

• Self-motivated and able to work with limited supervision

• Experience in medical device, pharmaceutical, or regulated industry

• Knowledge of 21 CFR 820, ISO 13485, and/or Canadian medical device regulations

• Onsite office, seated computer work

• Regular inbound/outbound customer communication

• Maintain consistent attendance and professional workflow