Job ID R-416169 Date posted 11/16/2021

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

Primary Responsibilities and Duties
1. Responsible for Quality Systems as assigned,
2. Responsible for application of assigned Quality Systems in a manner that meets the scope of storage and distribution processes.
3. Responsible for monitoring assigned Quality System performance through established metrics and/or Quality objectives, addressing under performance and escalation with appropriate leadership when required.
4. Collaborates with functional process owners to train, mentor and/or facilitate QMS requirements, continuous process improvement.
5. Maintains awareness of, and follows applicable Corporate Quality procedures

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.

The Quality Systems Specialist will be accountable for Quality Systems as the off-shift Subject Matter Expert (SME), ensuring compliance to the following Quality Systems as assigned:

  • Holds and product disposition and movement within the WMS/SAP

  • Zero Escape

  • Intracompany Claims

  • QMS Audits

  • Metric Data Analysis

  • Operations Support

  • SME for ISO 13485, 21 CFR 820, and Corporate Policies / Procedures when appropriate.

  • Where assigned, responsible for ensuring site is meeting the terms and obligations of local wholesale drug licenses as the Designated Representative for the 2nd shift.

  • Support regional improvement goals, annual Quality objectives, integration and optimization as assigned. 

  • Other duties and responsibilities as assigned.

Sphere of Influence:

  • Works under general direction of the Quality Manager.   

  • Determine and pursue courses of action necessary to obtain desired results.

  • Plans and participates in disciplines strategically relevant to the business and/or functions

  • Participates in site projects and initiatives where applicable

  • Considered Site / Functional Subject Matter Expert (both process & IT applications) for assigned processes.

Essential Functions:

* Working knowledge and application of ISO 13485 and 21 CFR 820.

* Subject matter expert of Quality Systems Regulatory requirements and  application tools

* Excellent communication, problem solving, organizational and interpersonal skills are essential.

Qualifications:

  • A minimum of 5 years relevant experience or a combination of equivalent education and relevant experience in Medical Device and/or Pharmaceutical regulated industry within Quality, Supply Chain and/or Distribution Center operations. 

  • Computer skills (Excel, Word, Power Point, etc.) 

  • Self-motivated and directed, requiring minimal supervision

  • Demonstrated ability to work in teams to obtain results is required.

  • Effective skills in analytical thinking and problem solving required

Education/Degree:

  • BA/BS Degree in Quality Engineering, Supply Chain, Business Management, or related Science discipline preferred. A combination of equivalent education and experience may be accepted in lieu of a bachelors degree. 10 years experience in a regulated environment and high level of proficiency with SAP, WMS, and other ERP platforms.

  • Certifications (if applicable)

  • Industry Recognized certification in a Quality System Element specialty, (e.g ASQ Certified Quality Auditor, etc.) preferred.

Employment at BD is contingent upon the Company’s receipt of sufficient proof that you are or will be fully vaccinated against COVID-19.  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 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 IN - Plainfield

Additional Locations

Work Shift

US BD 2nd Shift 230pm-11pm (United States of America)
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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

BENEFITS

Healthcare

401(k)/
Retirement Plans

Professional Development

Paid Time Off

Awards &
Recognition

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Plainfield

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