Job Description Summary

Job Description

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 Summary

• Under the direction of the Designated Complaint Handling Unit Lead, handles activities and procedures associated with IDS product complaints.

• Accountable for setting own work direction and completing work tasks.

• Supervise the processing of customer complaints including maintenance of complaint files, responses to customers and Quality reports.

• Responsible for a variety of mechanical and functional product evaluations related to the investigation of customer complaints. As well as supporting Market Segment Teams.

• Able to lead the end-to-end process of customer complaints including utilization of the database systems used to process complaints.

• Responsible for processing of customer complaints specifically Medical Device Reports (MDR’s), including maintenance of complaint files, responses to customers and complaint reports.

• Provide guidance and education regarding customer complaint processing, MDR’s, complaint report ability, and regulatory compliance.

• Fills out decision trees when needed, after appropriate complaint investigation and files MedWatch reports after Leader reviews and approves.

Job Responsibilities

• Develop, implement, and follow procedures to ensure timely and accurate receipt, logging, analysis, and response to customer complaints. Reviews all customer complaints for validity and assures complaints are processed in compliance with policies and procedures.

• Provide guidance, review and generates MDR reports in accordance with BD procedures and FDA regulations.

• Contribute to the business-wide quality strategy and quality objectives

• Maintain systems to monitor and facilitate the timely investigations and close out of open complaints. Ensure complaints are investigated and completed in a timely manner.

• Monitor and communicate significant complaint trends, adverse events, and other pertinent reports

• Provides and analyzes organizational quality metrics as required to assess the effectiveness of quality system improvements. Provide internal awareness of noted trends and complaint issues via periodic and ad hoc reports as required by the business unit/platform team.

• Interact with Health Care Workers, Consumers and other professionals regarding their Product Quality concerns on an as needed basis.

• Ensure the customer complaint investigation, procedures, and activities comply with applicable FDA and ISO requirements for complaint handling and adverse event reporting.

• Exhibit flexibility and adaptability by leading assignments in accordance with project priorities and by altering course of action when and where necessary

• Ensure ethical responsibility to maintain privacy and confidentiality of patient records and private information.

• Represents IDS on cross-business teams related to Quality Systems.

• Partners with other quality professionals to address recurring issues identified throughout the organization.

• Provides Education: Provides on-going education and training of new and current staff on product usage, common complaint scenarios, appropriate data capture, regulatory requirements, and initial and ongoing assessment

Qualifications

Education and Experience

• Bachelors in a science-related field

• One (1) year or more experience in the complaint handling / trending, Medical Device industry, Medical Device Reporting, FDA regulations, GMP, Quality Systems and where applicable clinical and other laboratory functions.

• Experience in health care setting where BD or similar products are used, e.g., clinical labs, hospitals, ICU’s, health care delivery settings.

Knowledge and Skills

• Extensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, and ISO 13485 / 14971

• Product knowledge – must have solid understanding of product usage and failure modes. Ability to differentiate between significant and non-significant health risks (to either the patient or health care worker)

• Using computer based analytical, statistical, and modeling tools to identify and improve processes, must be proficient in excel, and be able to quickly develop proficiency in SAP complaint handling systems

• Strong analytical, deductive reasoning and listening skills

• High level of problem identification, analysis, and formulation of conceptual / technical and business solutions

• Ability to influence without authority and deal optimally with ambiguity

• Must be able to communicate precisely and accurately to all levels of the organization

• Strong product knowledge of clinical application usage and/or manufacturing process

• Strong business, technical and digital literacy

• Strong project management skills

• Must be able to provide support to Customer Facing Teams

• Must be motivated, self-directed, and able to work with minimal supervision

• Ability to organize and prioritize assignments providing direction to assigned functional teams.

• Ability and skill to optimally handle multiple tasks and lead execution of change management plans.

• Ability and skill to lead or handle the Quality System function for complex systems, continuous improvement projects and project management techniques.

• Ability to act as a liaison across functions and with outside customer representatives or stakeholders concerning operational or project schedules/deliverables, audits, etc.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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 Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.

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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 or hourly rate 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 or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

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