Job ID R-455761 Date posted 11/20/2022

Be part of something bigger at BD. Here, you’ll help us continually improve how we do things every day; to be more efficient, more effective and better serve our customers. You’ll do this within an exceptional team all striving to make sure that everything we do complies with regulations and standards, not just because it’s the right thing to do, but because our products impact people’s quality of life. Here, you’ll put your compliance experience, high expectations and attention to detail to the very best use: advancing the world of health™. At BD, you can make a true difference of one.

  • Job Type:
    Full-Time
  • Job Level:
    Entry to Senior
  • Travel:
    Varies
  • Salary:
    Competitive
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Responsibilities

Job Description Summary

Job Description

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 70,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

The ideal candidate has 10+ years of Medical Device experience at Director or above level in 2+ Billion revenue companies

The Vice President, Design and Development Quality for the MMS-based Dispensing and Care Continuum business will be responsible for leading the developing, 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 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 executing 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 Safety Assurance Case practices.

The Vice President will be a member of the Cross-functional Dispensing Teams and as such they and team leadership will represent the interests of Quality and Compliance within the Medication Management Solutions business unit. 

The Vice President 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.

The Vice President, Design and Development Quality – Dispensing & Care Continuum 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.  As such, defining and maintaining a comprehensive Risk Management Program for all products is required and for Safety Assurance Cases, where required.  Included here are full responsibility for software and cybersecurity quality practices. This position is responsible for understanding where poor quality in design may impact our stakeholders 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.

Responsibilities:

  • This leader will be the single point of contact for Dispensing GMs (2) for all Quality and compliance matters. They will be responsible to develop strategic quality programs to oversee and foster: Design changes for, 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 QIPs related to Pyxis Medical Device Upgrade and international QIP, includes ROWA and Parata

  • 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, Software, 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 execute 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 20 total years’ experience, with at least 15 years’ experience leading a Quality Engineering Team in the Medical Device Industry supporting Class II/III devices
  • 10+ years of Medical Device experience at Director or above level in 2+ Billion revenue companies
  • Demonstrated expert-level knowledge of Design Controls, Software Engineering, 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 (50+ 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)

Click on Apply if this sounds like you!

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 empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do 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. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

To learn more about BD visit https://jobs.bd.com/

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.

Primary Work Location

USA CA - San Diego TC Bldg C&D

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Advancing the world of health™

BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.

BD is unique in how fully dedicated it is to a specific disease state. It makes it clear how the work we do directly impacts the daily lives of the patients we serve.


Eric Rainis
Senior Director Quality Management

To know that our products touch 30 million people with diabetes around the globe is powerful and fuels our teams to deliver best in class products to them each and every day.


Bridget Bagnato
VPGM Injection

It is inspiring to see BD products to be used globally to advance human healthcare.


Yang Zeng
Manager Medical Laboratory

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