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 Description SummaryPrimary responsibilities include assuring the DC maintains a robust, effective Quality Management System that complies with applicable regulations and BD procedures. The role will provide Quality supervision for quality processes on the distribution floor (holds, quarantine, damages, scrap, returns, rework, etc.). Operates under direct line supervision to the Manager, Quality Management, US Distribution Centers.
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.
Duties and Responsibilities:
1) Oversee and assure the DC maintains a robust, standardized and effective Quality System which complies with applicable regulatory requirements and Quality Agreements established with business units served.
2) Responsible for leading local site implementation of annual Quality Objectives and Key Business Drivers established for DC operations.
3) 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.
4) 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.
5) Ensure effective implementation and execution of Quality processes conducted under the Quality Systems to accomplish expected requirements and performance.
6) Utilize metrics and reporting to effectively monitor processes, report on performance, drive improvement, and provide cost savings to the business.
7) 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 synergistic activities.
8) 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.
9) Maximize the benefits for the overall system to drive Business, Supply Chain performance and customer satisfaction.
10) 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.
11) 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.
12) CPR-036 Subject Matter Expert facilitating training to DC personnel and direction where correct identification of damaged product is unclear and/or escalation to the business is required for final disposition.
Partner with the businesses and provide summary input on key packaging and configuration issues in order to maintain document currency to product and customer requirements.
13) Effectively evaluate and provide direction to the DC with inventory that has suspected damage and is at risk of being scrapped.
14) Manage the non-conformance process (Quality Notification/QN), collaborate on issues to provide detailed information to source plants, vendors, or carriers to determine root cause. Partner with and/or review Operation’s investigations and effective corrective actions to drive solutions that reduce damage and risk in future shipments.
15) Oversee and monitor the scrap process to ensure compliance to procedure, timelines, and regulatory requirement (Hazwaste, etc.).
16) Facilitate the escalation process with businesses and Social Investing group as applicable where disposition of inventory identified for scrapping or donation to charitable organizations is not meeting established timelines.
17) Subject Matter Expert for DC Quality Non-Conforming processes (Hold, Quarantine, Damages, Rework, Returns, Temperature Control, Etc.) facilitating training, coaching and direction. Ensures compliance to standardized processes.
18) Designated business unit Quality representative for facilitation and supervision of remediation/rework activities with DC personnel. Provides on-site training on behalf of the business units on rework protocols when required.
19) Collaborate with Transportation on carrier related issues and driving claims to resolution where escalation is needed. Also assist Supply Chain and partner with BD businesses on carrier related issues where root cause analysis and corrective actions are initiated to improve carrier performance.
20) Partner with Operations and Supply Chain Relations on customer related issues and driving claims to resolution where escalation is needed.
21) Conduct and participate in audits as required in compliance with regulatory requirements, e.g. ISO 13485, 21 CFR 820.
22) Other duties as assigned.
23) For most roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In limited circumstances, weekly testing for COVID-19 may be available instead of vaccination. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Total 5 years experience with 1+ years supervisory or leadership experience
Experience in Supply Chain and/or Distribution Center Operations preferred
Minimum of 2 years 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
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 results
- BS Degree in related Engineering or Science preferred, or equivalent work experience
ISO 13485 and 21 CFR 820 Lead Auditor certified preferred
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 LocationUSA GA - Covington Global Dist Center
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.
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.
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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.
It is inspiring to see BD products to be used globally to advance human healthcare.
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