Senior Director, Quality Management, EMI OUS Operations & OEM

Eysins , Vaud, Switzerland

Type: n/a

Category: IT & Internet & Media

Requirements: English
Company: BD
Region: Eysins , Vaud

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 its no small feat. It takes the imagination and passion of all of usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto 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, youll 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

As Senior Director, Quality Management, EMI OUS Operations & OEM you will be responsible for developing and maintaining quality assurance programs, policies, procedures, and controls for pre-production supplier qualification, capability development, and manufacturing quality for both internal OUS (Outside of the United States) and global contract manufacturing sites.

You will ensure the OUS manufacturing sites and contract manufacturers quality systems and quality management system meet requirements and standards, including BD corporate quality policies.

You will be responsible for overseeing quality design transfer, ensuring contract manufacturers have the skills and resources to meet business and manufacturing objectives. This role manages both operational and design transfer quality across internal manufacturing sites and the various contract manufacturers.

Main Responsibilities Will Include

• Develop strategic quality programs to oversee and foster: process capability, new products supplied component readiness and introduction, product improvements, material changes, operations quality and supplier quality expert-level leadership and guidance for a dedicated team.
• Define and influence a quality culture.
• Multi-BU authority and accountability for developing, deploying, and maintaining a robust and compliant quality management system for the design, risk management, and ongoing life-cycle maintenance of BD products.
• Actively identify improvements to the processes within the QMS.
• 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.
• Provide operations and supplier quality leadership during FDA and notified body site inspections. Interface with the FDA on Post-Market Activities: site inspections, manufacturing complaints, additional information requests.
• Assess resource needs to align the required level of quality support provided when needed with suitable competencies, including shifting resources between Platforms when appropriate.
• Maintain effective design-related quality metrics and define and execute activities to improve performance.

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, affectio

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