Manager Quality Engineering

4 weeks ago

Sunnyvale, United States Intuitive Surgical Full time
Job Description

Primary Function of Position:

This person leads and functionally manages the Quality Engineering group.  You will interface with leaders including VPs and Directors throughout the design, operations, regulatory, IT, marketing and service areas of Intuitive Surgical.  Quality Engineering is primarily responsible for measuring quality and helping the company apply those data quickly, intelligently and consistently.  Quality Engineering is broadly responsible for or a stake-holder in Product Quality; Data Quality; Process Quality; Corrective Action Preventive Action (CAPA); Lessons Learned; Solutions to challenging quality problems; Design for Quality in new product; Organizational input to our Quality Review Board; Organization of Enterprise data for quality; Functional specification of Quality enterprise software.

Roles & Responsibilities:

  • Being a proponent of Product Quality throughout the organization; including the ability to work pragmatically and cooperatively with leaders throughout the company to deliver high-quality product to market quickly, continuously improve it, and rapidly fix problems.
  • Working in close cooperation, with a shared vision, with leadership from Quality Assurance, Supplier Quality, Incoming Quality Control, Business Analytics, and others, and communicating throughout the organization.
  • Leading and functionally managing the Quality Engineering group (skills and gap assessment, talent acquisition, and development).

Quality Engineering is primarily responsible for:

  • Organizing sources and internal customers for quality data; identifying ways across the enterprise to close quality loops more quickly.  Structuring needed quality metrics to help others measure themselves and assess the cost of quality appropriately.  Facilitating the use of good tools and techniques overall.
  • Gathering and making available to enterprise customers a routine set of quality data for their weekly use (standard quality reports).
  • Owning the Nonconformance and CAPA systems, leading teams that monitor quality data, ensuring that analyses and documentation meet standards. 
  • Facilitating weekly product quality meetings and driving high performing teams to focus on product quality enhancements.
  • Running periodic Quality Data review meetings and cross functionally to address needs.
  • Ensuring that risk estimation is done well at all levels of the organization (Risk Assessment, Failure Mode Evaluations, Process Risk Assessments, Health Hazard Analyses).
  • Communicating Lessons Learned to design teams, supplier-facing teams, etc.
  • Project-managing Continuous Improvement projects.

Quality Engineering is a stakeholder and shares responsibility for:

  • Setting data-driven priorities for continuous improvement of ISI products and processes.
  • Ensuring quality/reliability/safety is built into ISI designs, while coordinating with Design Engineering, Manufacturing Engineering, and Supplier Quality.
  • Ensuring adequate design control throughout the product life cycle and Quality Engineering deliverables are met.
  • Ensuring data quality, process quality for anything that affects ISI product or patient outcome, including the improvement of SOPs, DOPs, etc.
  • Generating risk assessments for product in the field, including recall assessment (with Regulatory Compliance)
  • Supporting deep technical failure analysis, root cause analysis, resolution, and prevention for challenging quality issues.

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