Director, Supplier Quality Management
Job Description Summary
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.
The Director ensures suppliers quality systems and quality management systems meet requirements and standards, including DS quality policies. Supplier quality teams report directly to the director and are under their authority for performance reviews, career development, compensation, hiring, and termination. The director also partners with manufacturing, supply chain and procurement leaders, operating with independence to strengthen and improve supplier management and governance.
Responsible for ensuring that suppliers continue to develop and implement best practices that stress non-conformance prevention, reduction in variation and waste, as well as provide for continuous improvement. The Director collaborates with peers to support operations and supplier quality and compliance within each business unit.
Job Description
We are 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.
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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 makerof possible with us.
Key Responsibilities
Actively identify improvements to the processes within the QMS to enhance both compliance and quality of products delivered from supplier Responsible for building 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 Other assignments as directed by the Vice President Quality Management EMI .
Education
Bachelor's degree in a technical field required. Engineering degree strongly preferred. Master's degree in a technical field preferred.
Experiences
Minimum of ten (10) years' experience in the following areas: Electromechanical Instrumentation, Quality Assurance/Control, Statistical analysis, FDA QSR's (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 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.
To learn more about BD visit https://bd.com/careers
Required Skills
Optional Skills
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Primary Work Location
USA MD - Sparks - 7 Loveton Circle
Additional Locations
USA NC - Mebane, USA PR Cayey - Vicks Drive
Work Shift
At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.
Salary Range Information
$163,000.00 - $293,300.00 USD Annual
Perks and Benefits
Health and Wellness
Parental Benefits
Work Flexibility
Office Life and Perks
Vacation and Time Off
Financial and Retirement
Professional Development
Diversity and Inclusion