Job Description Summary

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. 

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.

This role will be responsible for leading the development, establishment and maintenance of Quality Assurance and Engineering programs, processes and controls during design, development, and transfer; ensuring that performance and quality of new products in Parata/Pharmacy Automation platform conform to product requirements, established standards and regulations, and exceed customer expectations. Success will be measured by robust Verification and Validation prior to launch that translate to high product quality performance post launch that exceed customer expectations.  Through internal and external stakeholder engagement and personnel development, this role ensures that projects produce high quality products, compliant and on-time deliverables and efficient execution. Product safety, product quality, product reliability and compliance with all members of Core Teams and Program Management will be ensured through effective communication, excellent problem solving and active management of ambiguous situations. 

Pharmacy Automation. https://parata.com/

This position leads a platform new product 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, Verification and Validation activities, Reliability Engineering, Human Factors, Test Method Development and Validation Safety Assurance Case practices

The position will be a member of the Cross-functional Parata Platform Team and as such they and team leadership will represent the interests of Quality and Compliance.

This leader shall be proficient in the development of design process requirements and leading the core team through the necessary diligence and decisions related to conformance to those requirements throughout the new product development life cycle.

Design Excellence—While quality principles are well-founded in the 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 Pharmacy Automation products.

Responsibilities

• This leader must develop strategic quality programs to oversee and foster: Design changes, New Products, product enhancements, 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 specific portfolio of Pharmacy Automation 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 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 development.
• Platform-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.
• Actively identify improvements to the processes within the QMS to enhance both complian