Job ID R-411468 Date posted 09/14/2021

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.

  • Job Type:
    Full-Time
  • Job Level:
    Entry to Senior
  • Travel:
    Varies
  • Salary:
    Competitive
  • Glassdoor Reviews and Company Rating

Responsibilities

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.

BD in Sparks MD has an opportunity to join us as a Quality Systems Specialist! This position is accountable for working cross functionally in the application, understanding and compliance of Quality Systems. The Quality System Specialist reports to the Manager, Quality.

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.

Responsibilities:

  • Manage and maintain an effective local Quality organization, training and development programs, subject matter expertise, define and assign associates’ responsibilities, succession plans, establishing annual IIG’s and evaluating performance

  • Assure the Distribution Center maintains a robust, standardized and effective Quality System which follows all requirements and agreements

  • Lead local site implementation of annual Quality Objectives and Key Business Drivers established for DC operations

  • Promote a culture of Quality across the local organization so that everyone has an understanding of and dedication to ISO and QSR regulations as they apply to Storage, Distribution and Transportation

  • Utilize metrics and reporting to effectively measure processes, report on performance, drive improvement, and provide cost savings to the business

  • Employ and share best practices and tools to accelerate continual quality improvement into DC organization locally and across the region, initiating lessons learned and best practice concepts; to introduce pro-active improvement and prevent recurrence of issues

  • Serves as a Designated Representative as appropriate to ensure day to day operations meet states’ licensing requirements for medical device and/or wholesale drug distribution regulations as applicable.

  • Accountable for ensuring compliance to the following Quality Systems:

    • Document and record control, DMS Administrator

    • Training & Curricula / C2C DLA / GMP & GDP

    • Order Fulfillment Claims support for root cause analysis and SCARs

    • Intracompany Claims

    • QMS Audits

    • Metric Data Analysis

    • Non-conforming processes

    • Supplier Management

  • Assist in the execution of CAPAs, Validations, Calibration, and Environmental Monitoring

  • Conduct and participate in audits in compliance with regulatory requirements

People reporting to you include:

  • Quality Lead, Quality Clerks, Quality Associate

Requirements:

  • BS Degree in Quality Engineering or related field or equivalent work experience

  • At least 3 years of experience in a regulated environment

  • Digital literacy (Excel, Word, Power Point, etc.)

  • Continuous Improvement Experience

  • Strong people leadership including developing, coaching, listening, collaborating, and delegating

  • Demonstrate excellent organizational, analytical, process efficiency, interpersonal and communication skills

  • Project leadership skills

  • Initiative and drive for results

Preferred:

  • Experience in Supply Chain and/or Distribution Center Operations

  • Experience in medical devices and/or pharmaceutical industry

  • Knowledge and experience with Medical Device regulations, ISO 13485 and 21 CFR 820

  • ISO 13485 and 21 CFR 820 Lead Auditor certified

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 MD - Sparks - 26 Loveton Circle

Additional Locations

Work Shift

US BD 1st Shift 830am-5pm (United States of America)
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Success Profile

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  • 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

BENEFITS

Healthcare

401(k)/
Retirement Plans

Professional Development

Paid Time Off

Awards &
Recognition

Working in

26 Loveton Circle

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