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 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.

QUALIFICATIONS

• Bachelor’s degree in engineering, Life Sciences, or a related field (advanced degree preferred).
• Minimum 15 years of progressive experience in Design Quality Assurance within the medical device industry.
• At least 6 years of direct management experience.
• Proven experience in New Product Development and Sustaining Engineering.
• Strong critical thinking, analytical, and decision-making skills.
• Excellent verbal and written communication skills; assertive and collaborative leadership style.
• Demonstrated ability to lead cross-functional and cross-regional teams.
• Experience managing professional and technical QA staff.
• Deep knowledge of global medical device regulations (FDA, EU MDR, etc.).
• ASQ certification (Engineer or Manager) preferred.
• Six Sigma Green Belt or Black Belt certification preferred.
• Experience in manufacturing, project management, or engineering is a plus.
• International experience and ability to manage global teams and stakeholders.

KNOWLEDGE AND SKILLS

• In-depth knowledge of:
• 21 CFR Part 820

• 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.
• Support the Corrective and Preventive Action (CAPA) process.
• Lead a team of Quality Managers and Engineers, operating with a high degree of autonomy.
• Initiate and lead cross-functional, strategic projects relevant to the business.
• Act as a subject matter expert (SME) at the site and functional level.