Complaint Management Specialist

Primary Responsibilities And Duties

• Manage the process of the complaint handling system including, receipt of complaints from all sources and all in end-to-end complaint process steps.
• Checking for complaint accuracy and content, correct information to process the complaint.
• Triage complaint and determine required information needed to assist in reportability decisions and robust product investigations.
• Follow procedures to ensure timely and accurate execution/review of decision trees.
• Draft and Submit MDRs (Medical Device Reports) as needed to with the FDA.
• Ensures compliance with all BD policies and procedures.
• Routing the complaint to appropriate location for further evaluation.
• Interface/Communicate with Customers via Phone, Chat, Email as needed.
• 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.
• 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.
• Contact customers as needed to provide updates to outstanding quality issues.
• Review of complaint prior to closure for accuracy and appropriateness of the letter content as well as follow up acknowledgement notice, if required.
• 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 BD 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 systems to monitor and facilitate the timely reporting of MDRs and supplemental MDRs.
• 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.

Requirements (Knowledge, Skills, And Abilities)

• Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, ISO 13485 and Canadian Regulations.
• Product knowledge: understanding of product usage and the ability to differentiate between significant and non-significant health risks to either patient or healthcare worker).
• Knowledge of product failure modes.
• Ability to work with customer 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.
• 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.
• Continuous and versatile learner.