Quality System Specialist 2

• Manage activities and procedures associated with complaints concerning BD products including reviewing customer complaints and potentially filing the Medical Device Reports (MDR’s) associated with complaints to the FDA
• Processing of product complaints including but not limited to customer communication (e.g. Email’s, phone calls) and interacting with health care workers, consumers and other professionals regarding their product quality concerns
• Maintenance of complaint files and responses to customers
• Create final letters and or review for accuracy to ensure that all customers’ requirements have been met
• Escalation of quality issues, in order to get resolution and or Business responses for the customer
• Manage the process of the complaint handling system including, receipt of complaints from all sources and all in process steps including data entry
• 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
• Follow procedures to ensure timely and accurate review of customer complaints and filing of MDRs with the FDA
• Ensures compliance with all BD policies and procedures
• 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
• 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
• 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 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

• 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
• 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
• 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
• Continuous and versatile learner
• Licensed Medical Professional desired such as Registered Nurse (RN), Med Technologist, Biomedical Engineer

Licensed Medical Professional desired such as Registered Nurse (RN), Med Technologist, Biomedical Engineer