Complaint Handling Management Specialist

• Medical Device Product Complaint Handling
• Medical Device Reporting (FDA)
• Manage intake and reporting of the product complaint handling process including, receipt of complaints from all sources (including Service Cases and Work Orders) and 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
• Acknowledgement 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 call’s… etc
• 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
• Remain current in product knowledge and any upgrades to complaint handling systems
• 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
• May perform other duties as required

• Minimum 1+ years of experience with medical terminology, Nursing, Clinical or laboratory knowledge and familiarity with BD products
• Minimum 2+ years of experience in the complaint handling, medical device industry, customer relations, complaint trending, FDA/ISO regulations
• Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, ISO 13485, and Canadian Regulations
• Ability to work with customers, system administrators, and clinicians
• Proven ability to maintain a professional demeanor when handling complex user issues and high-pressure situations
• 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
• Life Science, Nursing, Medical Clinical Scientific or another relevant field
• In lieu of degree: Combination of Educations and Experience is considered

Medical Device Experience a plus