Job Details

Sr. Mgr, Quality Engineering (Electromechanical)

BD is one of the largest global medical technology companies. Advancing the world of health^™ is our Purpose, and it's no small feat. It takes imagination and passion of all of us—from design and engineering to manufacturing and marketing of billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Position Summary

The Senior Manager of EMI (Electromechanical Instrumentation) 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. It 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

• Provide input into and support the Director of EMI Quality development of the overall EMI sustaining quality strategy.
• Work with the respective BU platform teams when a design change is needed in support of sustaining projects.
• Drive the customer‑facing lens of quality with a focus on instrument performance at install and while in the field.
• Lead teams to deliver improvements to drive instrument reliability.
• Develop quality programs to oversee and foster process capability, new product supplied component readiness and introduction, product enhancements, material changes, operations quality and supplier quality.
• Define and influence a quality culture that enables rapid transformation of ideas to requirements to products and diligent compliance to internal quality management system requirements.
• Actively identify improvements to processes within the QMS to enhance 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 required quality support with suitable competencies, including shifting resources between platforms.
• 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.
• Minimum 3‑year of direct management experience, preferably with managing engineers.
• Working knowledge of ISO 14971, MDD/MDR, IVDD/IVDR, MDSAP, CMDR, ISO 13485, J‑PAL, and FDA QSR's (21 CFR Part 820).

Required Knowledge And Skills

• Experienced in project management.
• Organizational / motivational skills.
• Capable of managing a range of projects and activities in parallel.
• The ability to manage by influence in addition to functional responsibility.
• Preparation, planning, and presentation of key initiatives.
• The ability to coordinate effectively across regions.

Salary

$158,300.00 – $261,100.00 USD Annual. Salary may vary by location.

Location & Shift

Primary Work Location: USA CA - San Diego TC Bldg C&D. Work Shift: 4 days in‑office per week (remote or field‑based arrangements may apply).

Equal Opportunity Employer

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 status, civil union status, familial status, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally‑protected characteristics.