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. 

Position Summary

The Senior Manager of EMI (Electromechanical Instruementation) Quality Sustaining Engineering reports to the Global Director of EMI Quality. This role is responsible for planning and execution of Sustaining Engineering activities to keep products in compliance with applicable standards and improve customer experience. This role also assists in developing and maintaining quality assurance programs, policies, procedures, and controls for pre-production supplier qualification, capability development, and manufacturing quality. It ensures product performance and quality meet requirements, standards, and regulations for all BU EMI product platforms.

Sustaining Quality engineers at the EMI plant locations will report directly to the Senior Manager and are under their authority for performance reviews, career development, compensation, hiring, and termination. The Senior Manager also partners with operational or platform team leaders, operating with independence but under oversight from senior quality and regulatory compliance leaders.

Key Responsibilities

• This leader will provide input into and support the Director of EMI Quality development of the overall EMI sustaining quality strategy.

• This leader will work with the respective BU platform teams when a design change is needed in support of sustaining projects.

• This leader will drive the customer facing lens of quality with a focus on instrument performance at install and while in the field.

• They will drive teams to deliver on improvements to drive improvement instrument reliability.

• This leader will develop quality programs to oversee and foster: process capability, new products supplied component readiness and introduction, product enhancements, material changes, operations quality and supplier quality expert-level leadership and guidance for a dedicated team.

• 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 developing them.

• Actively identify improvements to the processes within the QMS to enhance both compliance and quality.

• Provide expert-level understanding of qualification and validation, nonconformance control, process capability, risk reduction, and supplier management requirements and how to deploy them in a large-scale and rapidly evolving business.

• Provide operations and quality leadership during FDA and notified body site inspections.

• Interface with the FDA on Post-Market Activities: site inspections, manufacturing complaints, additional information requests.

• Acquire and develop excellent-level leaders and teams to support the EMI mission and actively manage bench-strength and succession planning.

• 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.

• Other assignments as directed by the Director of EMI Quality.

Education

• Bachelor’s degree in a technical field required. Engineering degree strongly preferred. 

• Master’s degree in a technical field preferred.

Experience

• Minimum of ten (10) years’ experience in Quality Assurance and Risk Management

• Minimum of three (3) years’ experience with electromechanical instrumentation devices

• Working knowledge of (ISO 14971), and ISO/EC (MDD/MDR, IVDD/IVDR, MDSAP, CMDR, ISO 13485, J-PAL) requirements, Quality Assurance/Control, Statistical analysis, and FDA QSR’s (21 CFR Part 820)