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BD (Becton, Dickinson and Company) Quality System Specialist II in Franklin Lakes, New Jersey

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 Complaint Management Center Lead, manages activities and procedures associated with IDS product complaints.

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

  • Responsible for making recommendations to the management team regarding continuous improvement of department work processes and operating procedures.¬† Participate in High Performance Work Teams.¬† Provide direction and coordination to warehouse team relative to specific quality focus areas ‚Äì Damage Processors, Returns Processors, Auditors.¬† Actively participate in quality programs and quality project teams.¬† Assist Quality Manager in preparing procedures, work instructions, shipping papers, Quality Data Review, Management Review, and any other duties assigned to meet requirements.

  • Developing solid understanding of applicable regulatory, Corporate and/or Unit requirements. Specifically: Ensure Customer complaint investigations, procedures, and other activities follow FDA Quality System Regulations, ISO, and Medical Device Directives for Vigilance.

  • Coordinates all types of mobility cases from consulting phase through the lifecycle of the move until completion. Actively executes the process ensuring timely completion of cost analysis, approvals, assignment letter generation and review, system updates, compensation accumulation, year-end tasks, invoice review, and other related administrative transactions

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

  • Providing guidance to the end-to-end complaints process, including regulatory reporting

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

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In this role you will be also responsible for:

To ensure the safety of our associates, BD supports remote work where possible. This position is based in the listed location but is temporarily remote-based due to Covid-19. We are continuing to monitor the situation and follow local governmental guidance to advise when is the right time and safe for our associates to return to their BD work location.

To be successful in this role, you should be able to demonstrate:

  • 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.

  • Completes and processes BD Peripheral Intervention reports including but not limited to: sales summary reports, expense reports, monthly product tracking reports, account targeting reports, and complaint reports in accordance with established procedures and policies.

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

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

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

  • Provides and analyzes organizational quality metrics as required to assess the efficiency 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 follow applicable FDA and ISO requirements for complaint handling and adverse event reporting. .

  • Dedication to Partnership & co-operation, information sharing but also flexibility changing environments

  • 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 ongoing education and training of new and current staff on product usage, common complaint scenarios, appropriate data capture, regulatory requirements and initial and ongoing assessment.

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Education and competences required:

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Skills:
  • Strong analytical, deductive reasoning and listening skills

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

  • Ability to deal well with ambiguity

  • Ability to communicate precisely and accurately

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

  • Effective analytical, technical, and problem-solving skills.

  • Strong project management skills

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Basic Requirements:
  • Solid understanding of regulatory standards applicable to design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO 14971 and IEC 60601 and collateral standards highly desired

  • Medical device standards and FDA guidance relevant to medical devices.

  • Must have knowledge of product failure modes. Demonstrate competence in mechanical and functional risk assessment.

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

  • One (1) years 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.

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Education:
  • Minimum of BS Degree in Medical Technology, Biomedical Engineering or related healthcare / Engineering field.

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.

#li-pro

Why join us?

A career at BD means that you are part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here you can fulfill your life’s purpose through the work that you 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://bd.com/careers

“BD values equity in the workplace without discrimination for any disability, class, ethnicity, age, religion, gender identity or sexual orientation.”

Primary Work LocationUSA NJ - Franklin Lakes

Additional Locations

Work Shift

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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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