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Senior QA Engineer - Digital

Company: GE Healthcare
Location: Waukesha
Posted on: January 8, 2021

Job Description:

Job description:This position is responsible for providing quality engineering process support to GE Healthcare Edison Platform and digital solutions in accordance with GE Healthcare medical device Quality Management System (QMS). 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 quality and compliance activities around Software Development Projects including Edison.

Roles and Responsibilities

  • Assists in ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
  • Leads, develops, communicates & implements a quality and compliance strategy.
  • Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site.
  • Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools, utilizing the Agile/Lean methods and traditional project management methods.
  • Works with engineering teams closely to drive quality excellence of Edison Platform and applications, including design reviews, processes/practices simplification, quality system training, etc.
  • Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).
  • Utilizes risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc. Supports design mitigation efforts. Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process.
  • Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation. Required profile:Required Qualifications
    • Bachelor's Degree in Engineering, Computer Science or equivalent
    • Minimum 5 years' experience in Quality Assurance / Regulatory Affairs
    • Minimum 3 years' experience in software within a regulatory industry
    • Practical knowledge of software development and familiarity with Software Development Lifecycle (SDLC) in medical device or healthcare software development environment.
    • Experience with Agile/Lean software development methods
    • Ability to effectively communicate technical information in English (both written and oral). Desired Characteristics
      • Familiarity with Agile/Lean software development lifecycle process. ScrumMaster experience is preferred.
      • Strong leadership and communication skills. Previous project management experience is 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 expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management. Company description:GE Healthcare is a medical technology and diagnostics business with a vision to become the leading innovator enabling precision health. With us, you can touch the lives of thousands of people globally and make every moment matter in your career.What we offer:GE Healthcare is a medical technology and diagnostics business with a vision to become the leading innovator enabling precision health. With us, you can touch the lives of thousands of people globally and make every moment matter in your career.

Keywords: GE Healthcare, Waukesha , Senior QA Engineer - Digital, Engineering , Waukesha, Wisconsin

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