Director, Quality Management, EMI Supplier Management
About the Role
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 BU product platforms that leverage suppliers.
We are looking for a proven leader with over ten years of experience in Electromechanical Instrumentation, Quality Assurance, FDA QSR's, lean manufacturing and ISO standards to join our team.
Main Responsibilities:
1. Actively identify improvements to the processes within the QMS to improve compliance and quality of products delivered from supplier.
2. 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.
3. Support design, development, and manufacturing operations toward resolution of supplier quality problems as well as the implementation of corrections and corrective actions.
4. Provide supplier quality leadership during FDA and notified body site inspections.
5. Maintain effective supplier-related quality metrics and define and execute activities to improve performance.
6. Ensure the review and evaluation of supplier quality data to identify process improvement opportunities within the supply chain.
7. Support the establishment of a deliberate and disciplined Critical-to-Quality (CTQ) program driving focus and capability on critical supplier processes and associated characteristics.
8. Ensure supplier activities remain in compliance with domestic and international medical device standards, directives, and regulatory requirements.
9. Promote 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).
10. Ensure 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.