Customer Complaint Handling Management Specialist - Urgent Need

Primary Responsibilities and Duties

• Medical Device Product Complaint Handling
• Medical Device Reporting (FDA)
• Manage intake and reporting of the product complaint handling process
• Receipt of complaints from all sources (including Service Cases and Work Orders)
• All in process steps complaint determination, Data entry, Critical Thinking to request additional information (as needed), reportability decisions, MDR filing, and serve as point of contact for customer communication
• Routing the complaint to appropriate location for further evaluation
• Entering of the complaint into the complaint handling system
• Checking for complaint accuracy and content, correct information to process the complaint
• Provide training to personnel involved in overall complaint process as directed by management
• Participates in all training classes including but not limited to, product training, regulatory training, compliance training and any testing involved
• Maintains annually competencies through training and documentation of training
• Contact the customer or vendor for further information or follow up
• Acknowledgment to the customer of receipt and status of the complaint if needed
• Sample routing when applicable, to the investigation site
• Interact with Health Care Workers, consumers, public and other professionals regarding their Quality concerns
• Maintain customer relations via multiple means, written, verbal, phone calls
• Answering of Inbound/Outbound Calls
• Contact customers as needed to provide updates to outstanding quality issues via phone/email
• Review of complaint prior to closure for accuracy and appropriateness of the letter content as well as follow up acknowledgement notice, if required
• Triage customer escalations and escalate to the Business units for response and resolution as needed
• Perform history check on previously submitted complaints by customer to ensure that the customer is receiving an appropriate closing response
• Ensure that the customer compliant complies with all relevant procedures
• Demonstrate technical competencies in mechanical, clinical, and functional in relation to all client products and areas
• Create and review closing letters for accuracy and to ensure right the first-time approach to customer communications
• Maintain expert knowledge level of the compliant handling system
• Provide feedback to management for compliant process improvement opportunities (e.g., complaints systems, final letters, escalations process, etc...)
• Provide training to peers as requested by management
• Raise any escalated customer concerns to the next level of management

KSA Requirements (Knowledge, Skills, And Abilities)

• Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, ISO 13485, and Canadian Regulations
• Proven ability to work with customers, system administrators, and clinicians
• Expert level knowledge of the Complaints handling system
• Proven ability to multi-task and seamlessly move between business unit platforms
• Ability to take ownership and think independently, with minimal supervision
• General knowledge of producing metrics and building reports
• Strong analytical, deductive reasoning and listening skills
• Must be able to communicate precisely and accurately to all levels of the organization
• Strong interpersonal skills
• Strong Project management skills
• Demonstrated aptitude for identifying creative solutions to complex customer issues’ ability to “think outside the box”
• Excellent time management and multitasking skills
• Excellent written and verbal communication skills
• Works well in a team environment
• Strong personal commitment to quality, customer service and patient safety
• Business and computer skills
• Must be motivated, self-directed, and able to work with minimal supervision