Job Description: Summary
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
Under the direction of the Complaints Management Manager, the Quality System Specialist II, will lead activities and procedures associated with complaints concerning BD products. This position will be responsible for processing of product complaints including but not limited to customer communication (e.g., Email's, phone calls), maintenance of complaint files and responses to customers. This position will build final letters and or review for accuracy to ensure that all customers' requirements have been met. This position will also be responsible for escalation of quality issues, to get resolution and or Business responses for the customer. Additional responsibilities may be delegated by the Complaints Management Manager as needed.
Primary Responsibilities and Duties
Execute 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, accurate 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 proficiencies 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 critical issues and advance 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 align with all relevant procedures
Demonstrate technical proficiencies 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 experienced knowledge level of the compliant handling system
Provide feedback to management for compliant process improvement opportunities (e.g., complaints systems, final letters, critical issues process, etc...)
Provide training to peers as requested by management.
Raise any advanced customer concerns to the next level of management
BA or BS degree preferred and/or combination of education and relative experience in lieu of a degree
Certifications (if applicable)
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.
Extensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, ISO 13485 and Canadian Regulations
Ability to work with customer system administrators and clinicians
Proven ability to maintain a professional demeanor when handling sophisticated user issues and high pressure situations
Experienced 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 direction
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 social skills
Strong Project management skills
Demonstrated aptitude for identifying creative solutions to complex customer issues' ability to "think creatively"
Excellent time management and multitasking skills
Excellent written and verbal communication skills
Works well in a team environment
Strong personal dedication to quality, customer service and patient safety
Business and digital literacy
Must be motivated, self-directed and able to work with minimal direction.
Click on Apply if this sounds like you!
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life's purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components - is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Primary Work Location
USA TX - San Antonio
BD (Becton, Dickinson And Company)