Description

• Capture, review, and analyze product complaints
• Communicate with customers directly via phone and email
• 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 request, 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
• Perform other duties as assigned
 

Skills:
• Bachelor degree required; in a Science, Math or Engineering related field is preferred
• 0-2 years of experience in a medical device, biologics, and/or pharmaceutical organization 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
• Demonstrated organizational, problem-solving, analytical and time management skills is desired
 

Competencies:
• Proficient with Microsoft Office (Excel, Word, and PowerPoint)
• Ability to learn database software
• Ability to follow documented procedures
• Ability to interface with both technical and non-technical personnel at all organizational levels
• Ability to read and understand technical documentation including investigations and Service Orders
• Ability to understand device, drug and/or biologic operational activities is desired
• Excellent interpersonal, written English, and oral communication skills

• This position works in an office type environment. Long periods of sitting are required. Use of computer and phone are required on a daily basis

Key Skills

Education

Bachelor's degree