Complaints Management

millenniumsoft•San Antonio, TX

7d•Hybrid

About The Position

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 (MDR’s) 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., Email’s, 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.

Requirements

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.
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, self-directed 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

Responsibilities

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.
May perform other duties as required