Director, Quality Engineering – WW IPD
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Job Description Summary
The Director, Quality Engineering – WW IPD is responsible for developing and leading the global Design Center Quality function for Infusion Preparation and Delivery (IPD) within BD’s Medical Delivery Solutions (MDS). This role ensures that all IPD products are designed and manufactured in compliance with applicable industry and regulatory standards and meet customer expectations for safety and effectiveness.Reporting to the VP, Quality Management WW IPD & MDS Manufacturing EMEA, the Director provides strategic leadership and technical support to Quality Engineering teams located in Brea, San Diego, and TCI. The role also ensures the maintenance of a robust Quality Management System (QMS) aligned with corporate policies and regulatory requirements, supporting both new product development and sustaining engineering activities.
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.
Job Summary
The Director, Quality Engineering – WW IPD is responsible for developing and leading the global Design Center Quality function for Infusion Preparation and Delivery (IPD) within BD’s Medical Delivery Solutions (MDS). This role ensures that all IPD products are designed and manufactured in compliance with applicable industry and regulatory standards and meet customer expectations for safety and effectiveness.
Reporting to the VP, Quality Management WW IPD & MDS Manufacturing EMEA, the Director provides strategic leadership and technical support to Quality Engineering teams located in Brea, San Diego, and TCI. The role also ensures the maintenance of a robust Quality Management System (QMS) aligned with corporate policies and regulatory requirements, supporting both new product development and sustaining engineering activities.
Responsibilities
Lead execution of unit-level Quality activities to achieve Business Driver Goals (BDGs), Key Driver Goals (KDGs), and quality performance metrics.
Drive continuous improvement initiatives and develop Quality strategies to enhance product quality and customer satisfaction.
Lead the Quality organization across Design Centers (San Diego, Brea, TCI), supporting compliance, sustaining engineering, new product development, and cost-reduction initiatives.
Accountable for disposable sets to ensure a system-level approach between pumps and sets, including alignment and consistency in risk management files, coordinated change control processes between pumps and sets and oversight of system performance of disposable sets
Act as the interface between Worldwide IPD and MMS for Design quality assurance, Quality Management System (QMS) alignment and compliance, and Inspection and audit readiness
Ensure the QMS meets or exceeds applicable regulatory requirements and industry standards.
Establish and maintain a Quality organizational structure that delivers excellent service and optimizes resource utilization.
Provide technical support for Post-Market Quality, including complaint investigations and situation analyses.
Deliver key inputs for IPD Management Reviews and ensure adherence to BD policies and procedures.
Support manufacturing sites with change control processes and problem-solving expertise to mitigate risks.
Develop and coach Quality team members, ensuring continuous improvement and capability development.
Keep senior leadership informed of quality performance and risk across the platform.
Lead Risk Management activities in compliance with ISO 14971 for products under design authority.
Serve as a member of the WW IPD Quality Leadership Team and actively participate in Quality Management Reviews (QMRs).
Contribute to Quality budget planning, resource allocation, and administration.
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