Quality Engineering Manager

Intuitive Surgical•Sunnyvale, CA

29d

About The Position

This person manages the Quality Engineering group within the Endoluminal 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.

Requirements

Good understanding of medical device company manufacturing operations and risk-based approaches to quality
Proven ability to build and manage teams and to project-manage cross-functionally
Strong analytic skills as proven by track record for analyzing and fixing complex problems in products and processes
Training or commensurate experience in the science of quality
Proven ability to lead and motivate across functional boundaries
Proven ability to manage through conflicting requirements and make difficult trade-offs when resources are scarce.
A passion for doing the vital thing, efficiently and well
Excellent judgment in the presence of competing priorities and incomplete data
Education: BS in Engineering degree (master's degree is preferred) or equivalent experience
8 or more year's experience, with 5 years in the quality arena working on a complex medical device product, or equivalent quality background; 1-3 years of experience as a people manager.
Travel requirement for this position is 10%

Responsibilities

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)
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.