Complaint and Returns Specialist

POSITION DESCRIPTION:

The Complaint and Returns Specialist is responsible for processing daily returns and coordinating complaint handling activities. This role supports operational efficiency, customer satisfaction, and regulatory compliance by managing fulfillment workflows and resolving product-related concerns.

The Complaint and Returns Specialist provides guidance to team members, collaborates across departments, and ensures service levels are consistently met. This position also serves as the primary contact for low-risk product complaints, supporting investigation, documentation, and communication processes in accordance with internal procedures.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Complaint Handling:

• Primary contact for all customer experience reporting and complaint handling activities related to manufactured products.
• Receives, documents, investigates, and tracks product complaints in accordance with internal protocols.

• Initiates and participates in investigations and corrective action arising from product complaints.

• Collaborates with Sales Team, Support Services, Engineering, Manufacturing, and Quality Assurance departments in investigations.
• Ensures timely completion of complaint failure investigations and communicates with management and team members to ensure appropriate actions are taken to maintain/restore timeliness goals.
• Identifies process improvements to enhance complaint management efficiency and compliance.
• Ensures complaint investigation documentation and records are complete and in compliance with regulatory requirements.

• Adhere to all relevant standard operating procedures and regulatory requirements including cGMP, ISO 13485, and 21CFR Part 820.

Returns:

• Processes customer returns daily utilizing QAD to receive and transfer incoming materials to designated locations.
• Collaborates with the Quality department to ensure proper communication and thorough analysis of high-risk cases.
• Reviews record documentation and follow-up activities to ensure accuracy, completeness, and adherence to required timelines.
• Manages and processes RMA cases through to resolution, ensuring compliance with company policies.
• Maintains a thorough understanding of required data collection for technical issues, adverse events, and reportable complaints to support regulatory compliance.
• Provides timely follow-up and status updates to customers and sales representatives regarding open cases.
• Document and process product returns, including issuing credits upon approval.
• Respond to customer inquiries regarding return status, credit issuance, and product replacement.
• Coordinate with Inventory Control (IC) to facilitate product restocking through dock-to-stock or manufacturing rework as needed.
• Support data collection and analysis for return trends, including Pareto analysis.
• Processes and sorts returned products efficiently and in accordance with company procedures.
• Verifies returned products against the associated Return Material Authorization (RMA) case number.
• Notifies internal support teams of any returned products that are not linked to an RMA.
• Reconciles returned product quantities within the Enterprise Resource Planning (ERP) system.
• Proactively communicates with customers regarding outstanding product returns at 30, 60, and 90-day intervals.
• Provides timely return status updates upon request from internal support teams.
• Ensures customers receive appropriate credit for returned products, if applicable.
• Inspects returned products, verifies return reasons for accuracy, and conducts root cause analysis.
• Sterilizes returned products that may have been in contact with patients to ensure compliance with safety standards.
• Coordinates restocking of undamaged products to maintain inventory efficiency.
• Collaborates with the Quality department to assess and analyze high-risk return cases.
• Utilizes QAD to receive and transfer incoming materials to designated locations.
• Reviews record documentation and follow-up activities to ensure completeness and adherence to timelines.
• Closes return cases in compliance with established guidelines and required deadlines.
• Maintains a thorough understanding of company policies, departmental processes, and associated procedures.
• Ensures accurate collection and documentation of data related to technical issues, adverse events, and reportable complaints to support regulatory compliance.
• Other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

• High School diploma or equivalent required.
• Minimum of 3 years of experience in returns processing, inventory management, or a related field within manufacturing.
• Strong attention to detail with the ability to identify discrepancies and maintain data accuracy.
• Strong analytical and critical thinking skills to support investigation and root cause analysis.
• Basic proficiency in Microsoft Excel, including data entry, sorting, filtering, and basic formulas.
• Excellent verbal, written, and interpersonal communication skills, with the ability to work across departments.
• Ability to work effectively as part of a team in a fast-paced environment.
• Salesforce experience preferred, particularly for return tracking and case management.
• QAD experience preferred, with a focus on inventory transactions and reconciliation.
• Must be able to fulfil the physical requirements of the position, including lifting or moving items up to 50 pounds and standing for extended periods.
• Ability to learn technical concepts by reading work instructions and standard operating procedures and completing on-the-job training.
• Knowledge of cGMP regulations ISO 13485, 21CFR Part 820, CMDR SOR/98-282, 93/42/EEC, RDC 16 2013, MHLW MO 169 and TG(MD)R Sch3 preferred.