Job Description

Summary:

The primary responsibility of this position involves the daily management of commercial Product Quality Complaints. The daily management of complaints may include but is not limited to, complaint file creation, identifying trends, processing metrics, ensuring timely investigations, and closing complaints through the system promptly.

Job Responsibilities:

• Capture, review, and analyze product complaints.
• Communicate with customers directly via phone and email and Identify customer feedback related to services, products, and processes.
• Comply with relevant global product quality-related guidelines, standards, and regulations regarding the receipt, review, investigation, and reporting of product experiences
• Identify and understand the differences between product quality complaints, adverse events/incidents, medical information requests, customer feedback, and regulatory agency requests
• Collaborate with Field Personnel, Quality, Engineering, and/or Operations personnel to process complaints in a timely fashion
• Initiate, coordinate, review, and summarize investigations for complaints
• Perform product return evaluations, as required
• Identify potential product performance issues and alert the appropriate Management personnel, as required
• Escalate quality and/or safety concerns reported/experienced by the customer
• Work in conjunction and effectively communicate with various departments, including R&D, Engineering, Marketing, Medical Affairs, Technical Service, and Customer Care
• Provide support during audits and regulatory inspections, as required

Skills:

• A bachelor's degree required; in a Science, Math, or Engineering-related field is preferred.
• 2 years of experience in a medical device, biotech, or pharmaceutical industry is desired.
• Experience in a regulated cGMP environment is desirable
• Knowledge of regulations and standards (21CFR 820, 21CFR 803, 21CFR 210/211, MDD, ISO 13485, CMDCAS, MDSAP, EU MDR, etc.); as they apply to complaint management is desired

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