BD Nogales Norte
Sr. Mgr, Quality Engineering (Electromechanical)
BD Nogales Norte, San Diego, California, United States, 92189
Overview
Sr. Mgr, Quality Engineering (Electromechanical) BD Nogales Norte – 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. 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 report to the Senior Manager and are under their authority for performance reviews, career development, compensation, hiring, and termination. The Senior Manager 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 in the development of the overall EMI sustaining quality strategy. Collaborate with BU platform teams when a design change is needed to support sustaining projects. Drive the customer-facing lens of quality with a focus on instrument performance at install and in the field. Lead teams to deliver improvements to 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 leadership for a dedicated team. Define and influence a quality culture enabling rapid transformation of ideas into requirements and products while ensuring compliance with internal QMS requirements in design and development. 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, 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, and information requests. Acquire and develop leaders and teams to support the EMI mission and manage bench-strength and succession planning. Assess resource needs to align quality support with suitable competencies, including shifting resources between platforms as needed. Maintain design-related quality metrics and execute activities to improve performance. Demonstrate 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 three (3) years of direct management experience, preferably with managing engineers. Working knowledge of ISO 14971, ISO/EC (MDD/MDR, IVDD/IVDR, MDSAP, CMDR, ISO 13485, J-PAL), Quality Assurance/Control, Statistical analysis, and FDA QSRs (21 CFR Part 820). Required Knowledge and Skills
Experienced in project management. Strong organizational and motivational skills. Ability to manage multiple projects in parallel. Ability to influence beyond direct reports and across functions. Strong planning, preparation and presentation skills for key initiatives. Ability to coordinate effectively across regions. Note: For most roles, BD requires on-site collaboration with a minimum of 4 days in the office per week; remote or field-based roles will have different arrangements indicated in the posting. Employment may be contingent upon proof of full vaccination against COVID-19, with accommodations considered under applicable law. Why Join Us?
A career at BD means being part of a team that values your opinions and contributions, encourages you to bring your authentic self to work, and supports learning and growth every day. BD aims to help you reinvent the future of health and to thrive in a culture of collaboration and accountability. To learn more about BD, visit https://bd.com/careers. Salary Range Information
$158,300.00 - $261,100.00 USD Annual
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Sr. Mgr, Quality Engineering (Electromechanical) BD Nogales Norte – 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. 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 report to the Senior Manager and are under their authority for performance reviews, career development, compensation, hiring, and termination. The Senior Manager 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 in the development of the overall EMI sustaining quality strategy. Collaborate with BU platform teams when a design change is needed to support sustaining projects. Drive the customer-facing lens of quality with a focus on instrument performance at install and in the field. Lead teams to deliver improvements to 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 leadership for a dedicated team. Define and influence a quality culture enabling rapid transformation of ideas into requirements and products while ensuring compliance with internal QMS requirements in design and development. 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, 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, and information requests. Acquire and develop leaders and teams to support the EMI mission and manage bench-strength and succession planning. Assess resource needs to align quality support with suitable competencies, including shifting resources between platforms as needed. Maintain design-related quality metrics and execute activities to improve performance. Demonstrate 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 three (3) years of direct management experience, preferably with managing engineers. Working knowledge of ISO 14971, ISO/EC (MDD/MDR, IVDD/IVDR, MDSAP, CMDR, ISO 13485, J-PAL), Quality Assurance/Control, Statistical analysis, and FDA QSRs (21 CFR Part 820). Required Knowledge and Skills
Experienced in project management. Strong organizational and motivational skills. Ability to manage multiple projects in parallel. Ability to influence beyond direct reports and across functions. Strong planning, preparation and presentation skills for key initiatives. Ability to coordinate effectively across regions. Note: For most roles, BD requires on-site collaboration with a minimum of 4 days in the office per week; remote or field-based roles will have different arrangements indicated in the posting. Employment may be contingent upon proof of full vaccination against COVID-19, with accommodations considered under applicable law. Why Join Us?
A career at BD means being part of a team that values your opinions and contributions, encourages you to bring your authentic self to work, and supports learning and growth every day. BD aims to help you reinvent the future of health and to thrive in a culture of collaboration and accountability. To learn more about BD, visit https://bd.com/careers. Salary Range Information
$158,300.00 - $261,100.00 USD Annual
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