Summary

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.

This role will lead a team based in Durham, NC, and will report to the Platform Leader of Quality, Pharmacy Automation.

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

• Identify Quality Initiatives to address field Quality issues, define prevention mechanisms for future development projects and lead cross-functional teams to complete them.
• Effectively partner with R&D to define deliverables and troubleshoot technical issues. Engage with (or may lead) quality networks as well as the business unit and associates toward the effective promotion and alignment of organizational goals to the company’s mission and vision.
• Interface as required with the FDA on Pre-Market Activities: Design Controls, Risk Management, Test Methods, Safety Assurance Case, Human Factors
• 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.
• Other assignments as directed by the Platform Leader of Quality, Pharmacy Automation .
• Maintain effective design-related Quality Metrics and define and execute activities to improve performance. Actively support and demonstrate the BD values in daily work.
• Represent the Quality Function in all product planning activities, such as the Platform Development Team (PDT)
• Cross-functional influence and negotiation, and
• Assess resource needs to align the required level of quality support provided when needed with suitable competencies, including shifting resources between Platforms when appropriate.
• Actively identify improvements to the processes within the QMS to enhance both compliance and quality.
• 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.
• Broad organizational change management.
• Acquire and develop leaders and teams to support the Pharmacy Automation new product strategy and actively manage bench-strength and succession planning.
• Provide diligent and fact-based communication to Executive Management team, peers, and team.
• Ensure effective design transfer between development and manufacturing
• Development of teams including succession planning
• Serves as Quality Program Leader for complex new product development projects. Ensures successful development, verification, validation, and transfer of design. Monitor and influence key support functions that enable these goals including Supplier Quality, Sourcing, Manufacturing Risk Management, etc.
• Provide Design and Development leadership during FDA and Notified body site inspections.
• Organization design and deployment,
• Provide expert-level understanding of design control requirements and how to deploy them in a large-scale and rapidly evolving business.

Requirements

• Experience leading or supporting FDA and/or Notified Body inspections
• Demonstrated knowledge in Software development lifecycle, including familiarity with embedded software and firmware, applications software and analytics; knowledge of cybersecurity process for medical devices is highly desirable.
• Excellent communication skills (up, down, and outward)
• Strong leadership skills with demonstrated ability to deliver excellent results
• At least 10 years of experience managing Quality Engineers in a Design Assurance Organization
• A least 15 years of engineering experience in the Medical Device Industry supporting Class II/III devices or other regulated industry.
• ASQ certifications CQE, CSQE, CRE, CMQ/OE, CSSGB and/or CSSBB highly desired.
• Ability to travel up to 25%
• Prior leadership experience in Pharmacy Automation or other capital equipment medical product with broad experience with complex, electromechanical, and software devices
• Strong project management, team skills, and influential management also highly desired
• 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.
• Expert knowledge of methods for designing robust/reliable products including design review, verification & validation testing, trace matrix, risk management, design planning, Statistical sampling/plan selection
• Expert knowledge of FDA Design Controls, ISO 13485, and standards and regulations covering Medical Devices.
• Requires a minimum of a BS degree in science, engineering, or relevant discipline

Primary Work Location

USA NC - Research Triangle Park

Additional Locations

Work Shift