Faça parte de algo maior na BD.Aqui, você nos ajudará a melhorar continuamente a forma como fazemos as coisas todos os dias; para ser mais eficiente, mais eficaz e melhor servir os nossos clientes. Você fará isso dentro de uma equipe excepcional, todos se esforçando para garantir que tudo o que fazemos esteja em conformidade com os regulamentos e padrões, não apenas porque é a coisa certa a fazer, mas porque nossos produtos afetam a qualidade de vida das pessoas. Aqui, você colocará sua experiência em conformidade, altas expectativas e atenção aos detalhes da melhor maneira possível: Impulsionar o mundo da saúde™. Na BD, você pode fazer a verdadeira diferença de um.
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Responsabilidades
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 makerof 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 forDesign 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.
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
MDD 93/42/EEC
MDR 2017/745
ISO 13485
ISO 14971
Expertise in:
Design Controls
Change Control
Risk Management
Process Validation
Non-conformance and deviation handling
Test Method Validation
Supplier Qualification
Post-Market Surveillance
CAPA and Root Cause Analysis
Statistical Analysis
Strong strategic planning and prioritization skills.
Ability to lead and influence in a matrixed, global organization.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
You will learn and work 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. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.
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, you’ll 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.
To learn more about BD visit https://bd.com/careers
Required Skills
Optional Skills
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Primary Work Location
USA CA – BreaAdditional Locations
USA CA - San Diego TC Bldg C&DWork Shift
NA (United States of America)At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.
Salary Range Information
$179,200.00 - $322,500.00 USD AnnualPerfil de Sucesso
What makes a successful Quality Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Ambicioso
- Colaborativo
- Orientado para Objetivos
- Persuasivo
- Resultados
- Iniciador
Impulsionando o mundo da saúde™
BD é uma das maiores empresas globais de tecnologia médica do mundo e está Impulsionando o mundo da saúde™ melhorando a descoberta médica, o diagnóstico e a entrega de cuidado. A BD ajuda os clientes a melhorar os resultados, reduzir custos, aumentar a eficiência, melhorar a segurança e expandir o acesso aos cuidados de saúde.