Senior QA Engineer - Digital
Company: GE Healthcare
Posted on: January 8, 2021
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
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
- Responsible for the development, implementation, and continuous
improvement of process effectiveness and efficiency at the
- 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
- 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
- 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
- Minimum 5 years' experience in Quality Assurance / Regulatory
- Minimum 3 years' experience in software within a regulatory
- 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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