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General Electric QA Lead Engineer in Madison, Wisconsin

Job Description Summary

This position is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. This is a key technical role responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business. The role involves hands-on work in the areas of design, design transfer, manufacturing, distribution, and/or service.

At GE Healthcare, our passionate people are creating the products, solutions and services our customers need to deliver the best patient care possible.

Job Description

Roles and Responsibilities

  • Ensures 100 percent quality and regulatory compliance in accordance with documented procedures

  • Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, Lean Manufacturing, 5S, SPC, etc.

  • Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site.

  • Supports continuous product and process improvement through detailed failure analysis for non-conformances

  • Investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions.

  • Utilizes risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, Fault Tree Analysis, Failure Mode Analysis, etc.

  • Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, etc.

  • Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.

  • Leads, acknowledges, develops, communicates & implements a strategy to ensure compliance.

Required Qualifications

  • Bachelor's Degree Required.

  • Minimum of 1-3 years’ experience working in a regulated industry or a Master’s degree

  • Ability to communicate effectively in English (both written and oral).

  • Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.

Desired Characteristics

  • Demonstrated expertise to effectively communicate within all levels of the organization around concepts of production & process controls; CAPA, risk management; product quality improvement using tools such as Lean Six Sigma, DFR, DMIAC, SPC, 5S, etc.

  • Certified Lean Six Sigma Green Belt preferred

  • ASQ Certified Quality Engineer preferred

  • Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.

  • Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance

  • Exceptional analytical, problem solving & root-cause analysis skills

  • Ability to multi-task & handle tasks with competing priorities effectively

  • Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

#LI-MA4

Additional Information

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer (https://assets.phenompeople.com/CareerConnectResources/GE11GLOBAL/en_global/desktop/assets/images/poster_screen_reader_optimized_w_supplement.pdf) . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

Relocation Assistance Provided: No

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