Risk Analyst

1 month ago

Sunnyvale, United States Intuitive Surgical Full time
Job Description

Primary Function of Position

Reporting to the Sr, Director of RAQA Audits, the Director of Global Supplier Quality provides overall quality management of global supplier base engaged in the development, production and distribution of Intuitive Surgical products. This position will partner with separate Supplier Engineering teams, Quality Engineering, Quality Systems & Compliance and global partners to define the overall Supplier Quality Management (SQM) strategy, including developing clear mission, vision, and priority setting. The personal will also be responsible for developing and maintaining a system, and standardized approach to SQM including global policies/procedures, quality agreements, forms/templates and supplier quality metrics etc. that are compliant with all applicable international regulatory requirements (e.g. FDA regulations, ISO 13485, MDSAP, European MDR/IVDR etc.). The Director shall also be responsible for assuring effective coordination of supplier/vendor audits, governance of the Supplier Corrective Action program and management of Approved Supplier List (ASL) in conjunction with global and Business Unit teams.

Essential Job Duties

  • Establish plan and performance metrics for SQM function in alignment with Intuitive Surgical’s 3-5 year priorities
  • Support development of suppliers to be: Agile, Tightly integrated with Intuitive Surgical, Capable, and Stable thereby ensuring a reliable and robust supplier base
  • Establish a high performing supplier quality team. Provide direction, oversight, coaching and mentoring.
  • Identify and implement means to manage work-load, schedule, and monitor performance targets.
  • Collaborate cross-functionally to develop and implement a highly effective supplier quality management program focused on innovative solutions to meet business challenges and deliver maximum value to the business.
  • Develop and report key supplier quality metrics to cross-functional management.
  • Identify, develop and implement strategic quality initiatives to ensure continuous improvement with respect to supplier quality performance.
  • Develop audit plan, manage audit schedule and perform audits and inspection per plan (either internally or by a 3rd party contractor.)
  • Perform supplier qualification and assessment activities per established procedures, including initial onboarding, maintaining the supplier files and updating the Approved Supplier List (ASL.)
  • Maintain the Approved Supplier List and implement the use of internal quality systems resulting in successful resolution of supplier quality problems and performance issues
  • Continually evaluate and report on supplier quality performance, identify problem areas and assist with implementing supplier corrective actions as required.
  • Perform other duties as assigned.

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