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. 

POSITION SCOPE

The Warehouse Quality Specialist is accountable for working cross functionally in the application, understanding and compliance of their assigned Quality Systems. The Warehouse Quality Specialist reports to the Warehouse Management

RESPONSIBILITIES

• Coordinate and assure the DC maintains a robust, standardized and effective Quality System which aligns with applicable regulatory requirements and Quality Agreements established with business units served.

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

• Ensure the DCs’ processes, organization, procedures, and activities are adequate to effectively meet the needs of the US Supply Chain and conform to all applicable regulatory requirements and regional standards.

• Promote a culture of Quality across the local organization that ensures management commitment and understanding of ISO and QSR regulations as they apply to Storage, Distribution and Transportation.

• Ensure effective implementation and execution of Quality processes conducted under the Quality Systems to accomplish expected requirements and performance.

• Use metrics and reporting to effectively monitor processes, report on performance, drive improvement, and provide cost savings to the business.

• Lead and/or participate in regularly scheduled Quality Leadership calls to ensure timely implementation of agreed upon actions and facilitate cross site exchange of performance and collaborative activities.

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

• Improve the benefits for the overall system to drive Business, Supply Chain performance and customer satisfaction.

• Responsible for managing and maintaining an effective local Quality organization, training, development programs, subject matter expertise, defining and assigning associates’ responsibilities, succession plans, establishing annual IIG’s and evaluating performance.

• 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 Quality System as the local Subject Matter Expert (SME), providing guidance and training, facilitating meetings, critical issues, and ensuring compliance to the following Quality Systems as assigned:

  • Document and record control, DMS Administrator

  • Training & Curricula / C2C DLA / GMP & GD

  • 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 and Validations.

• Designated business unit Quality representative for facilitation of remediation/rework activities with DC personnel. Provides on-site training on behalf of the business units on rework protocols when required

• Partner with Operations and Supply Chain Relations on customer related issues and driving claims to resolution where escalation is needed.

• Conduct and participate in audits as required in compliance with regulatory requirements, e.g. ISO 13485, 21 CFR 820.

• Other duties as assigned.

POSITION REQUIREMENTS EXPERIENCE:

• Experience in Supply Chain and/or Distribution Center Operations preferred.

• Knowledge and experience in a regulated environment; experience in medical devices and/or pharmaceutical regulated industry preferred.

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

COMPETENCIES:

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

• Process oriented, Continuous Improvement Experience

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

• Excellent organizational, analytical and process efficiency skills

• Excellent interpersonal and communications

• Project leadership skills

• Initiative and drive for result

EDUCATION:

• Bachelor's Degree required

CERTIFICATIONS:

• ISO 13485 and 21 CFR 820 Lead Auditor certified preferred

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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