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Director, Supplier Quality Management
role at
BD
Overview The Director, Quality Management, Supplier Management reports to the Vice President of Quality. This role is responsible for developing and maintaining quality assurance programs, policies, procedures, and controls for pre-production supplier qualification and capability development. It ensures supplier performance and quality meet requirements, standards, and regulations for all product platforms that leverage suppliers.
Key Responsibilities
Actively identify improvements to the processes within the QMS to enhance both compliance and quality of products delivered from supplier.
Build out a robust supplier management process that drives supplier performance and accountability and balances quality, compliance and business aspects and risks.
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.
Supports design, development, and manufacturing operations toward resolution of supplier quality problems as well as the implementation of corrections and corrective actions.
Provide supplier quality leadership during FDA and notified body site inspections.
Acquire and develop excellent-level leaders and teams to support the DS 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 supplier-related quality metrics and define and execute activities to improve performance.
Ensures the review and evaluation of supplier quality data to identify process improvement opportunities within the supply chain.
Assists in the strategic definition, planning, and staffing of the Supplier Quality function to support Manufacturing and Operations Quality for long term tactical sustainability.
Supports the establishment of a deliberate and disciplined Critical-to-Quality (CTQ) program driving focus and capability on critical supplier processes and associated characteristics.
Determines and manages priorities within areas of responsibility.
Ensures supplier activities remain in compliance with domestic and international medical device standards, directives, and regulatory requirements.
Supports the development of an annual budget and aids in the control of spending.
Promotes the use of techniques for continuous improvement such as Lean, Six-Sigma, Poka-Yoke (Error Proofing), Measurement System Analysis and FMEA (Failure Mode and Effects Analysis).
Manages, coaches, and develops a high performing Supplier Quality team that meets agreed upon objectives which deliver best practice results, added value, and continuous improvement.
Ensures adequate staffing levels, recruitment, training, development, performance appraisal, attendance, disciplinary actions and daily supervision to maximize productivity.
Promotes high standards through leadership by example so that each member of the team understands the behavior standards expected of them.
Develops and maintains strong relationships with internal and external stakeholders to ensure optimal performance.
Ensures the execution of the supplier qualification/approval process, assessment of supplier QMS, as well as manufacturing and technology capabilities through onsite and virtual audit activities.
Drives through managers and/or engineering staff supplier validation activities using Advanced Product Quality Planning (APQP).
Reports supplier quality trends, performance, and other metrics to business unit leadership through Management Review activities and presentations.
Other duties and responsibilities as assigned by the Vice President Quality Management.
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 the following areas: Electromechanical Instrumentation, Quality Assurance/Control, Statistical analysis, FDA QSRs (21 CFR Part 820), lean manufacturing, risk management (ISO 14971), and ISO/EC (MDD/MDR, IVDD/IVDR, MDSAP, CMDR, ISO 13485, J-PAL) requirements.
Required Knowledge And Skills
Knowledge and application of ISO 13485, 21 CFR 820 and 21 CFR 210-211, MDD/MDR, IVDD/IVDR, requirements and European/US GMPs related to medical device and pharmaceutical manufacture.
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.
The preparation, planning and presentation of key initiatives.
The ability to coordinate effectively across regions.
Why Join Us? 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. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.
To learn more about BD visit bd.com/careers
Salary Range Information $163,000.00 - $293,300.00 USD Annual
Location
USA MD - Sparks - 7 Loveton Circle
USA NC - Mebane
USA PR Cayey - Vicks Drive
Employment type
Full-time
Seniority level
Not Applicable
Job function
Quality Assurance
Industries
Biotechnology Research, Medical Equipment Manufacturing, and Research Services
#J-18808-Ljbffr
Director, Supplier Quality Management
role at
BD
Overview The Director, Quality Management, Supplier Management reports to the Vice President of Quality. This role is responsible for developing and maintaining quality assurance programs, policies, procedures, and controls for pre-production supplier qualification and capability development. It ensures supplier performance and quality meet requirements, standards, and regulations for all product platforms that leverage suppliers.
Key Responsibilities
Actively identify improvements to the processes within the QMS to enhance both compliance and quality of products delivered from supplier.
Build out a robust supplier management process that drives supplier performance and accountability and balances quality, compliance and business aspects and risks.
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.
Supports design, development, and manufacturing operations toward resolution of supplier quality problems as well as the implementation of corrections and corrective actions.
Provide supplier quality leadership during FDA and notified body site inspections.
Acquire and develop excellent-level leaders and teams to support the DS 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 supplier-related quality metrics and define and execute activities to improve performance.
Ensures the review and evaluation of supplier quality data to identify process improvement opportunities within the supply chain.
Assists in the strategic definition, planning, and staffing of the Supplier Quality function to support Manufacturing and Operations Quality for long term tactical sustainability.
Supports the establishment of a deliberate and disciplined Critical-to-Quality (CTQ) program driving focus and capability on critical supplier processes and associated characteristics.
Determines and manages priorities within areas of responsibility.
Ensures supplier activities remain in compliance with domestic and international medical device standards, directives, and regulatory requirements.
Supports the development of an annual budget and aids in the control of spending.
Promotes the use of techniques for continuous improvement such as Lean, Six-Sigma, Poka-Yoke (Error Proofing), Measurement System Analysis and FMEA (Failure Mode and Effects Analysis).
Manages, coaches, and develops a high performing Supplier Quality team that meets agreed upon objectives which deliver best practice results, added value, and continuous improvement.
Ensures adequate staffing levels, recruitment, training, development, performance appraisal, attendance, disciplinary actions and daily supervision to maximize productivity.
Promotes high standards through leadership by example so that each member of the team understands the behavior standards expected of them.
Develops and maintains strong relationships with internal and external stakeholders to ensure optimal performance.
Ensures the execution of the supplier qualification/approval process, assessment of supplier QMS, as well as manufacturing and technology capabilities through onsite and virtual audit activities.
Drives through managers and/or engineering staff supplier validation activities using Advanced Product Quality Planning (APQP).
Reports supplier quality trends, performance, and other metrics to business unit leadership through Management Review activities and presentations.
Other duties and responsibilities as assigned by the Vice President Quality Management.
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 the following areas: Electromechanical Instrumentation, Quality Assurance/Control, Statistical analysis, FDA QSRs (21 CFR Part 820), lean manufacturing, risk management (ISO 14971), and ISO/EC (MDD/MDR, IVDD/IVDR, MDSAP, CMDR, ISO 13485, J-PAL) requirements.
Required Knowledge And Skills
Knowledge and application of ISO 13485, 21 CFR 820 and 21 CFR 210-211, MDD/MDR, IVDD/IVDR, requirements and European/US GMPs related to medical device and pharmaceutical manufacture.
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.
The preparation, planning and presentation of key initiatives.
The ability to coordinate effectively across regions.
Why Join Us? 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. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.
To learn more about BD visit bd.com/careers
Salary Range Information $163,000.00 - $293,300.00 USD Annual
Location
USA MD - Sparks - 7 Loveton Circle
USA NC - Mebane
USA PR Cayey - Vicks Drive
Employment type
Full-time
Seniority level
Not Applicable
Job function
Quality Assurance
Industries
Biotechnology Research, Medical Equipment Manufacturing, and Research Services
#J-18808-Ljbffr