Sr. Mgr, Quality Engineering (Electromechanical)

Senior Manager Of Electromechanical Instruementation Quality Sustaining Engineering

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 usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto 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

• 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.
• Drive teams to deliver on improvements to drive improvement instrument reliability.
• 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

Experience

Required Knowledge and Skills

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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.

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

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

Salary Range Information $158,300.00 - $261,100.00 USD Annual