Job ID R-396520 Date posted 04/19/2021

Be part of something bigger at BD. Here, you’ll help us continually improve how we do things every day; to be more efficient, more effective and better serve our customers. You’ll do this within an exceptional team all striving to make sure that everything we do complies with regulations and standards, not just because it’s the right thing to do, but because our products impact people’s quality of life. Here, you’ll put your compliance experience, high expectations and attention to detail to the very best use: advancing the world of health™. At BD, you can make a true difference of one.

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Job Description Summary

Job Description

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

Required Qualifications:


  • 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

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

Additional Locations

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Success Profile

What makes a successful Quality Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.

  • Ambitious
  • Collaborative
  • Goal-oriented
  • Persuasive
  • Results-driven
  • Self-starter

Advancing the world of health™

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. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.

BD is unique in how fully dedicated it is to a specific disease state. It makes it clear how the work we do directly impacts the daily lives of the patients we serve.

Eric Rainis
Senior Director Quality Management

To know that our products touch 30 million people with diabetes around the globe is powerful and fuels our teams to deliver best in class products to them each and every day.

Bridget Bagnato
VPGM Injection

It is inspiring to see BD products to be used globally to advance human healthcare.

Yang Zeng
Manager Medical Laboratory



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