Complaints Management

Job Title Complaints Management
Location : San AntonioTX

Duration 12 Months Contract
Total Hours/week 40.00
Shift Work days/hours : M F 8am 5pm(Initial training onsite. 1 day on site/the other 4 remote once training is complete)

Job Description

• Under the direction of the Complaints Management the Complaint Specialist will manage activities and procedures associated with complaints concerning BD products including reviewing customer surveys/ reviews and potentially filing the Medical Device Reports (MDRs) associated with complaints to the FDA.
• This position will be responsible for processing of product complaints including but not limited to customer communication (e.g. Emails phone calls) and interacting with health care workers
• consumers and other professionals regarding their product quality concerns.
• Additionally this position will be responsible for maintenance of complaint files and responses to customers.
• Additional responsibilities may be delegated by the Complaints Management as needed.

Primary Responsibilities and Duties

• Manage the process of the complaint handling system including receipt of complaints from all sources and all in endtoend 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 /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 calls 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 firsttime 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.
• May perform other duties as required

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 nonsignificant 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 highpressure situations
• Expert level knowledge of the Complaints handling system
• Proven ability to multitask 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.

Skills

• 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 selfdirected and able to work with minimal supervision.
• Continuous and versatile learner

Education/Degree

• BA or BSc degree in Science Engineering Health Administration Nursing or 2)yrs. relative experience and college courses in lieu of a degree.

Experience (in years)

• 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