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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 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.
BD is one of the largest global medical technology companies, advancing the world of health through innovative solutions. We foster a supportive environment for learning, growth, and development, encouraging our teams to become makers of possible. Join us to make a difference in healthcare and discover a culture that values your contributions and supports your professional journey.
Key Responsibilities include:
- Leading execution of unit-level Quality activities to achieve Business Driver Goals (BDGs), Key Driver Goals (KDGs), and quality performance metrics.
- Driving continuous improvement initiatives and developing Quality strategies to enhance product quality and customer satisfaction.
- Leading the Quality organization across Design Centers (San Diego, Brea, TCI), supporting compliance, sustaining engineering, new product development, and cost-reduction initiatives.
- Ensuring the disposable sets' system-level approach, including alignment and consistency in risk management, change control processes, and oversight of system performance.
- Acting as the interface between Worldwide IPD and MMS for Design quality assurance, QMS alignment, compliance, and audit readiness.
- Maintaining a QMS that meets or exceeds regulatory requirements and industry standards.
- Establishing and maintaining an effective Quality organizational structure.
- Providing technical support for Post-Market Quality, including complaint investigations.
- Delivering inputs for IPD Management Reviews and ensuring policy adherence.
- Supporting manufacturing sites with change control and problem-solving to mitigate risks.
- Developing and coaching Quality team members for continuous improvement.
- Keeping senior leadership informed on quality performance and risks.
- Leading Risk Management activities in compliance with ISO 14971.
- Participating in Quality Leadership Teams and Management Reviews.
- Contributing to Quality budget planning and resource allocation.
- Supporting CAPA processes and leading cross-functional projects.
- Acting as SME at site and functional levels.
Qualifications:
- Bachelor’s degree in engineering, Life Sciences, or related field; advanced degree preferred.
- Minimum 15 years of experience in Design Quality Assurance in the medical device industry.
- At least 6 years of management experience.
- Proven experience in New Product Development and Sustaining Engineering.
- Strong analytical, decision-making, and leadership skills.
- Excellent communication skills and a collaborative leadership style.
- Deep knowledge of global medical device regulations (FDA, EU MDR, etc.).
- ASQ certification and Six Sigma Green/Black Belt preferred.
- International experience managing global teams.
Knowledge and Skills:
- In-depth knowledge of regulations such as 21 CFR Part 820, MDD 93/42/EEC, MDR 2017/745, ISO 13485, ISO 14971.
- Expertise in Design Controls, Change Control, Risk Management, Process Validation, and related areas.
- Strong strategic planning and leadership skills in a global matrix organization.
Why Join Us? At BD, you'll be part of a team that values your opinions, encourages growth, and fosters an inclusive culture. We invest in your development through programs like BD University and offer a competitive benefits package. Join us to help shape the future of health and leave a lasting impact.
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