Sr. Director, Design Assurance, Infusion Platform Quality

Job Description

This role will be responsible for leading the development, establishment and maintenance of Quality Assurance and Engineering programs, processes and controls during design, development, and transfer; ensuring that performance and quality of new products in Infusion business conform to product requirements, established standards and regulations, and exceed customer expectations. Success will be measured by robust Verification, and Validation and strong transfer to manufacturing leadership prior to launch that translates to high product quality performance post launch that exceed customer expectations.

Through internal and external stakeholder engagement and personnel development, this role ensures that projects produce high quality products, compliant and on‑time deliverables and efficient execution. Product safety, product quality, product reliability and compliance with all members of Core Teams and Program Management will be ensured through effective communication, excellent problem solving and active management of ambiguous situations.

This role will lead a team based in San Diego, CA and will report to the Vice President of Design Quality Management, Infusion Platform and Development Quality.

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 Med Tech 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.

• This leader must develop strategic quality programs to oversee and foster:
  Design changes, New Products, product enhancements, material changes, software creation and maintenance and represent Design Controls expert‑level leadership and guidance for a dedicated team.
• This role is a highly matrixed and influential role having responsibility for a specific portfolio of infusion products’ design and development quality practices. As such, this leader must be mature in their understanding and execution of:
  • development of teams including succession planning
  • organization design and deployment,
  • cross‑functional influence and negotiation, and
  • broad organizational change management.
• Define and influence a quality culture that enables both rapid transformation of ideas to product requirements being diligent and deliberate in compliance to internal quality management system requirements.
• Platform‑wide 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 to enhance both compliance and quality.
• Provide expert‑level understanding of design control requirements and how to deploy them in a large‑scale and rapidly evolving business.
• Provide Design and Development leadership during FDA and Notified body site inspections.
• Interface with the FDA on Pre‑Market
  
  Activities:
  
  Design Controls, Risk Management, Test Methods, Safety Assurance Case, Human Factors
• Acquire and develop leaders and teams to support the Infusion new product platforms and actively manage bench‑strength and succession planning.
• Represent the Quality Function in all product planning activities, such as the Platform Development Team (PDT)
• Identify Quality Initiatives to address field Quality issues, define prevention mechanisms for future development projects and lead cross‑functional teams to complete them.
• Provide diligent and fact‑based communication to Executive Management team, peers, and team.
• Assess resource needs to align the required level of quality support provided when needed with suitable competencies, including shifting resources between Platforms when…