Under the direction of the Clinical Complaint Manager, the Specialist, will 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.
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. 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 as needed.
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
Job Responsibilities: (Primary Duties, Roles, and/or Authorities)
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.
Triage customer issues and escalate to the Business units for response and resolution as needed
Ensure that the customer compliant aligns 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.
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 intensified customer concerns to the next level of management.
May perform other duties as required
Education and Experience:
BA or BSc degree in Science, Engineering, Health Administration, Nursing, or (2) yrs. relative experience, and college course in lieu of a 4-year degree. RN licensed Preferred.
Minimum 3 years of experience with medical terminology, Nursing, Clinical or laboratory knowledge and familiarity with BD products
Minimum 3 years of experience with complaint handling, medical device industry, customer relations, complaint trending and FDA/ISO regulations.
Knowledge and Skills:
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
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
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.
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At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.
Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles.
Salary Range Information
$99,000.00 - $163,300.00 USD Annual