Manager, Quality Engineering

7 days ago

Sunnyvale, California, United States Intuitive Surgical Full time
Job Description

Primary Function of Position

This person manages the Quality Engineering group within the Single Port Business Unit and is responsible for maintaining and advocating product quality, leads an organization that is equipped to reach across the company acting as emissaries for the Product Quality mission.

Roles & Responsibilities

Leads New Product Introduction and Quality Operations for DaVinci Single Port (SP) Instruments, Accessories, and Endoscopes, responsibilities include:

    • Provide quality engineering support on product related issues arising from manufacturing using appropriate quality notifications; verify the adequacy of product impact assessments, dispositions, and any escalation decisions.
    • Drive continuous improvement initiatives by conducting trend analysis on reported manufacturing quality notifications and/or post market complaints.
    • Oversee the analysis of product failures and/or non-conformances; establish metrics and drive product and/or process improvement opportunities; drive failure investigations, review engineering assessments, and support projects that address said failures; identify and track metrics of improvement.
    • Work with senior leadership and cross-functional stakeholders to establish strategies, priorities, and goals for complaint reduction, cost of poor quality, trend analysis, process validation, statistical quality, and process control.
    • Provide subject matter expertise with change assessments (product and process), process validations, statistics, risk-based sampling, and measurement system analysis.
    • Partner with manufacturing teams to transfer products and processes into the production environment with high quality and support these products within the production environment.
    • Assess the need for any escalations for identified quality issues and assist the team members in performing escalation assessments and driving necessary corrective and preventive actions, as appropriate.
    • Lead and functionally manage the Quality Engineering group; assesses skills, performs gap assessment, prioritizes team/skill development; leads talent acquisition and budgeting activities.
    • Responsible for departmental and individual goal setting, goal tracking, correcting, and rewarding, as appropriate.
    • Represent quality management at monthly and quarterly review meetings (Quality Data & Operations Review)

In general, Quality Engineering is a stakeholder and shares responsibility for:

    • Setting data-driven priorities for continuous improvement of Intuitive's products and processes.
    • Ensuring quality/reliability/safety is built into Intuitive's product design by partnering with Design Engineering, Manufacturing Engineering, and Supplier Quality.
    • Ensuring data quality, process quality for anything that affects Intuitive's 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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