BD
Overview
Director, Supplier Quality Management at BD. Reports to Vice President of Quality. Responsible for developing and maintaining quality assurance programs for pre-production supplier qualification and capability development. Ensures supplier performance meets requirements, standards, and regulations for all product platforms that leverage suppliers.
Key Responsibilities
Identify improvements to QMS processes to enhance compliance and product quality from suppliers.
Build robust supplier management processes that drive performance and accountability, balancing quality, compliance, business risks.
Provide expert understanding of qualification/validation, nonconformances, process capability, risk reduction, and supplier management requirements; deploy in a large-scale, evolving business.
Support design, development, and manufacturing operations toward resolution of supplier quality problems and implementation of corrections and corrective actions.
Provide supplier quality leadership during FDA and notified body site inspections.
Acquire and develop leaders and teams to support DS mission; manage bench-strength and succession planning.
Assess resource needs to align quality support with suitable competencies; shift resources between platforms when appropriate.
Maintain supplier-related quality metrics and drive performance improvements.
Review and evaluate supplier quality data to identify process improvements within the supply chain.
Assist in strategic definition, planning, and staffing of Supplier Quality to support Manufacturing and Operations Quality long-term.
Establish a deliberate CTQ program for critical supplier processes.
Determine and manage priorities; ensure supplier activities comply with medical device standards, directives, and regulatory requirements.
Support development of annual budget and control spending.
Promote continuous improvement techniques (Lean, Six Sigma, Poka-Yoke, MSA, FMEA).
Manage, coach, and develop a high-performing Supplier Quality team; ensure staffing, training, performance appraisals, and supervision.
Promote high standards through leadership; develop strong relationships with internal and external stakeholders.
Oversee supplier qualification/approval process, supplier QMS assessment, and auditing activities.
Drive supplier validation activities using APQP (Advanced Product Quality Planning).
Report supplier quality trends and metrics to leadership via Management Review.
Perform other duties as assigned by Vice President Quality Management.
Education Bachelor’s degree in a technical field required; engineering degree strongly preferred; Master’s degree preferred.
Experience / Qualifications
Minimum of ten years in electromechanical instrumentation, Quality Assurance/Control, statistical analysis, FDA QSRs (21 CFR Part 820), lean manufacturing, risk management (ISO 14971), and ISO/EC requirements (MDD/MDR, IVDD/IVDR, MDSAP, CMDR, ISO 13485, J-PAL).
Required Knowledge and Skills
Knowledge and application of ISO 13485, 21 CFR 820 and 21 CFR 210-211, MDD/MDR, IVDD/IVDR, GMPs related to medical device and pharmaceutical manufacture.
Experience in project management.
Organizational and motivational skills.
Ability to manage multiple projects in parallel.
Ability to influence beyond formal authority.
Experience presenting key initiatives.
Ability to coordinate across regions.
Why Join Us BD is a leading global medical technology company. We value your opinions and contributions, support learning, growth, and accountability. You will work with inspiring leaders and colleagues in an inclusive, growth-centered culture. Opportunity to shape BD\'s trajectory and contribute to the BD University for ongoing skill development.
Salary Salary range: $163,000.00 - $293,300.00 USD Annual
Locations
USA MD - Sparks - 7 Loveton Circle
USA NC - Mebane
USA PR Cayey - Vicks Drive
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Key Responsibilities
Identify improvements to QMS processes to enhance compliance and product quality from suppliers.
Build robust supplier management processes that drive performance and accountability, balancing quality, compliance, business risks.
Provide expert understanding of qualification/validation, nonconformances, process capability, risk reduction, and supplier management requirements; deploy in a large-scale, evolving business.
Support design, development, and manufacturing operations toward resolution of supplier quality problems and implementation of corrections and corrective actions.
Provide supplier quality leadership during FDA and notified body site inspections.
Acquire and develop leaders and teams to support DS mission; manage bench-strength and succession planning.
Assess resource needs to align quality support with suitable competencies; shift resources between platforms when appropriate.
Maintain supplier-related quality metrics and drive performance improvements.
Review and evaluate supplier quality data to identify process improvements within the supply chain.
Assist in strategic definition, planning, and staffing of Supplier Quality to support Manufacturing and Operations Quality long-term.
Establish a deliberate CTQ program for critical supplier processes.
Determine and manage priorities; ensure supplier activities comply with medical device standards, directives, and regulatory requirements.
Support development of annual budget and control spending.
Promote continuous improvement techniques (Lean, Six Sigma, Poka-Yoke, MSA, FMEA).
Manage, coach, and develop a high-performing Supplier Quality team; ensure staffing, training, performance appraisals, and supervision.
Promote high standards through leadership; develop strong relationships with internal and external stakeholders.
Oversee supplier qualification/approval process, supplier QMS assessment, and auditing activities.
Drive supplier validation activities using APQP (Advanced Product Quality Planning).
Report supplier quality trends and metrics to leadership via Management Review.
Perform other duties as assigned by Vice President Quality Management.
Education Bachelor’s degree in a technical field required; engineering degree strongly preferred; Master’s degree preferred.
Experience / Qualifications
Minimum of ten years in electromechanical instrumentation, Quality Assurance/Control, statistical analysis, FDA QSRs (21 CFR Part 820), lean manufacturing, risk management (ISO 14971), and ISO/EC requirements (MDD/MDR, IVDD/IVDR, MDSAP, CMDR, ISO 13485, J-PAL).
Required Knowledge and Skills
Knowledge and application of ISO 13485, 21 CFR 820 and 21 CFR 210-211, MDD/MDR, IVDD/IVDR, GMPs related to medical device and pharmaceutical manufacture.
Experience in project management.
Organizational and motivational skills.
Ability to manage multiple projects in parallel.
Ability to influence beyond formal authority.
Experience presenting key initiatives.
Ability to coordinate across regions.
Why Join Us BD is a leading global medical technology company. We value your opinions and contributions, support learning, growth, and accountability. You will work with inspiring leaders and colleagues in an inclusive, growth-centered culture. Opportunity to shape BD\'s trajectory and contribute to the BD University for ongoing skill development.
Salary Salary range: $163,000.00 - $293,300.00 USD Annual
Locations
USA MD - Sparks - 7 Loveton Circle
USA NC - Mebane
USA PR Cayey - Vicks Drive
#J-18808-Ljbffr