Sr. Director, Quality, Dispensing

BD; San Diego (CA); On-site; USD 220,000 - 353,000; Full time

Job summary

BD is seeking a Sr. Director of Quality for the MMS-based Dispensing business in San Diego.

This role leads a global quality team, defining and executing quality strategies across design controls, risk management, cybersecurity, and software quality to ensure regulatory conformance and product excellence. The position encompasses pre- and post-market activities, cross-functional leadership, and responsibility for continued process improvements, including readiness for FDA inspections and ongoing

Qualifications

• BS degree in engineering, science, math or similar technical field with advanced leadership experience.
• Expert knowledge of design controls, risk management and cybersecurity for medical devices, plus software quality practices.
• Experience leading large cross-functional teams in a regulated medical device environment.
• Willingness to travel domestically and internationally up to 25%.

Responsibilities

• Lead the MMS quality program for dispensing products, overseeing design changes, new products, and product integrations.
• Drive global quality practices including design controls, risk management, test methods and life-cycle maintenance.
• Represent Quality in Platform Development Team activities and annual management reviews.
• Prepare for FDA and Notified Body inspections and maintain compliant QMS across sites.

Skills

Design Controls

Risk Management

Cybersecurity

Quality Engineering

Leadership

FDA inspections

Software Quality

Human Factors

Design for Six-Sigma

QA Strategy

Education

BS in Engineering/Science

Job description

We Are The People Who Give Possibilities Purpose

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.

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.

The Sr. Director, Quality for the MMS-based Dispensing business will be responsible pre and post market quality activities, including leading the development, establishment and maintenance of the quality assurance and engineering programs, policies, processes, procedures and controls during design, development and transfer; ensuring that performance and quality of Dispensing products globally conform to product requirements, established standards and regulations. This role will oversee both medical device and non-medical device products in these Quality function capacities. This role will lead a team based in San Diego, CA. and other global sites conducting design and development activities.

This position leads a broad Quality team and is charged with defining and completing superior Quality practices, in accordance with The BD Way and Quality Management Systems, for: Design Assurance and DFX programs, Design Quality Engineering, including sustaining design change activities, Software Quality Engineering (embedded, applications and analytics), Cybersecurity, Risk Management, Reliability Engineering, Human Factors, Test Method Development, and Validation.

The Sr. Director will be a member of the Cross-functional Dispensing Platform Teams, and as such, they and team leadership will represent the interests of pre and post market Quality and Compliance within the Medication Management Solutions business unit.

The Sr. Director will ensure that people and processes within the global Design & Development Quality function are capable of active management and improvement of product quality and compliance. This position reports to the VP of MMS Quality Management and is on the succession path for functional leadership.

Sr. Director, Dispensing will help drive the MMS business strategy as follows:

Product Risk Management – This position is responsible for the effectiveness of MMS Quality Management System and continued reduction of risks inherent in MMS products and services, both medical device and non-medical electromechanical products based. As such, defining and maintaining a comprehensive Risk Management Program for all products is required and for Safety Assurance Cases, where required. Included are full responsibility for software and cybersecurity quality practices. This position is responsible for understanding where poor quality in design may impact our partners using field feedback data and implementing prevention and improvement processes and projects to reduce that impact.

Design Controls Compliance

This position is responsible for ensuring the MMS Quality Management System elements affecting design and development are effective and efficient enabling risk control and reduction. Compliance to requirements is a must. This leader shall be proficient in the development of design process requirements and leading the organization through the necessary diligence and decisions related to conformance to those requirements throughout the product development life cycle.

Design Excellence

While quality principles are well-founded in our industry, the position is responsible for identifying superior processes to enable compliance and suitable product quality levels. Critical-To-Quality initiatives will be the driving force behind focusing this team on the critical characteristics of MMS products.

Automation and AI

This role should have an understanding of the latest uses of AI agentic tools and their application to Quality process, product and systems analysis and improvement.

Responsibilities

• This leader will be the single point of contact for Dispensing GM for all Quality and compliance matters. They will be responsible to develop strategic quality programs to oversee and foster: Design changes, New Products, product enhancements, product integrations, 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 broad global portfolio of Dispensing 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 global quality culture that enables both rapid transformation of ideas to requirements to products and diligent and deliberate compliance to internal quality management system requirements in design and developing them.
• MMS BU-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.
• Responsible for Quality Improvement Plans related to Pyxis Medical Devices
• 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 excellent-level leaders and teams to support the MMS mission and actively manage bench-strength and succession planning.
• Represent the Quality Function in all product planning activities, such as the Platform Development Team (PDT). Conducts Quarterly Management Reviews with GM staff
• 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 appropriate.
• Maintain effective design-related Quality Metrics and define and complete activities to improve performance. Actively support and demonstrate the BD values in daily work.
• Collaborate with functional peers to articulate Strategy and Execute
• Transfer of manufacturing facilities and validation
• Post Market Quality
• Efficiencies in complaint handling
• Build service quality capabilities
• Integrate open acquisitions and consolidate QMS
• Other assignments as directed by the MMS VP of Quality.

Requirements

• A BS degree in a technical field (Engineering, Science, Math/Stat)
• At least 15 years’ of experience leadership of increasing levels in the Medical Device Industry supporting Class II/III devices
• 8+ years of Medical Device experience at Associate Director or Director level in 500M+ revenue companies
• Demonstrated expert-level knowledge of Design Controls, Design for Six-Sigma, Critical-to-Quality strategies, Risk Management, Cybersecurity, Safety Assurance Cases, and Human Factors, etc.
• Demonstrated knowledge of mechanical, electrical and software engineering in the development of complex devices
• Demonstrated knowledge in Software development lifecycle, including familiarity with embedded software and firmware, applications software and analytics; knowledge of software quality for mobile device apps and remote installation is a plus
• Ability to travel domestically and internationally, up to 25%
• Strong leadership skills with demonstrated ability to deliver excellent results
• Experience leading large teams (30+ employees.)
• Strong project management, team skills, and influential management also highly desired
• ASQ certifications CQE, CSQE, CRE, CMQ/OE, CSSGB and/or CSSBB highly desired.
• Experience leading or supporting FDA and/or Notified Body inspections
• Broad experience with complex, electromechanical, and software devices
• Excellent communication skills (up, down, and outward)

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

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

To learn more about BD visit

https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills

Optional Skills

Primary Work Location

USA CA - San Diego Bldg A&B

Additional Locations

USA CA - Irvine Laguna Canyon, USA CA - San Diego (IDS), USA CA - San Diego - Otay Mesa

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$220,300.00 - $352,500.00 USD Annual