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.

Why join us?

A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.

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.

Become a maker of possible with us!

Our vision for Quality Management at BD

In our Quality team, we collaborate on a large scale, focusing on making sure everything is correct, effective and efficient to bring the highest-quality and most competitive products and services to our customers and their patients.

About the role

Job Description Summary

This role is responsible for developing and maintaining quality assurance programs, policies, procedures, and controls for pre-production supplier qualification and capability development. It ensures supplier performance and quality meet requirements, standards, and regulations for all BU product platforms that leverage suppliers.

In this role you will partner with manufacturing, supply chain and procurement leaders, operating with independence to strengthen and improve EMI supplier management and governance.

You will be responsible for ensuring that suppliers continue to develop and implement best practices that stress non-conformance prevention, reduction in variation and waste, as well as provide for continuous improvement.

Main responsibilities will include:

• Actively identify improvements to the processes within the QMS to improve compliance and quality of products delivered from supplier
• Provide expert-level understanding of qualification and validation, nonconformance control, process capability, risk reduction, and supplier management requirements and how to deploy them in a large-scale and rapidly evolving business.
• Supports design, development, and manufacturing operations toward resolution of supplier quality problems as well as the implementation of corrections and corrective actions.
• Provide supplier quality leadership during FDA and notified body site inspections.
• Maintain effective supplier-related quality metrics and define and execute activities to improve performance.
• Ensures the review and evaluation of supplier quality data to identify process improvement opportunities within the supply chain
• Supports the establishment of a deliberate and disciplined Critical-to-Quality (CTQ) program driving focus and capability on critical supplier processes and associated characteristics
• Ensures supplier activities remain in compliance with domestic and international medical device standards, directives, and regulatory requirements
• Supports the development of an annual budget and aids in the control of spending Promotes the use of techniques for continuous improvement such as Lean, Six-Sigma, Poka-Yoke (Error Proofing), Measurement System Analysis and FMEA (Failure Mode and Effects Analysis)
• Ensures the execution of the supplier qualification/approval process, assessment of supplier QMS, as well as manufacturing and technology capabilities through onsite and virtual audit activities
• Drives through managers and/or engineering staff supplier validation activities using Advanced Product Quality Planning (APQP)
• Reports supplier quality trends, performance, and other metrics to business unit leadership through Management Review activities and presentations.

About you

You are a proven leader with over ten years of experience in Electromechanical Instrumentation, Quality Assurance, FDA QSR's, lean manufacturing and ISO standards, you possess:

• Deep knowledge of medical device and pharmaceutical regulations such as MDD/MDR, IVDD/IVDR, MDSAP, CMDR, ISO 13485, J-PAL
• Outstanding project management and organizational skills.
• A track record of managing multiple projects simultaneously.
• The ability to influence and lead cross-functional teams.
• Strong communication skills for presenting key initiatives.

Click on apply if this sounds like you!

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.

To learn more about BD visit: https://bd.com/careers

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