What
do you envision for your future? At GE Healthcare, we strive to see
life more clearly. Our "healthymagination" vision for the future invites
the world to join us on our journey as we continuously develop
innovations focused on reducing healthcare costs, increasing access and
improving quality and efficiency around the world.
We are an $18 billion unit of General Electric Company (NYSE: GE),
employing more than 52,000 people worldwide and serving healthcare
professionals in more than 100 countries. We believe in our strategy -
and we'd like you to be a part of it. As a global leader, GE can bring
together the best in science, technology, business and people to help
solve one of the world's toughest challenges and shape a new age of
healthcare.
Something remarkable happens when you bring together people who are committed to making a difference - they do!
At work for a healthier world.
Experienced
Quality
Quality Assurance
Hungary
Budaors
2040
No
The
Software Quality Engineer (SWQE) provides software quality engineering
process support in accordance with documented Quality Management System
(QMS). He/she ensures each project is developed and released meeting
customer expectations and regulatory requirements related to software.
The SWQE is a key technical role that works closely with product
engineering to ensure successful design, development, testing &
design transfer and provides support for maintenance engineering.
Ensures quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
Reviews selected project work products to ensure compliance
to the Quality Management System and adherence to GEHC and appropriate
external standards.
Responsible for the 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.
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).
Develops 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
simple yet comprehensive procedures, work instructions, flowcharts,
forms, templates, checklists, worksheets, and other product and process
related documentation.
Bachelor’s
degree in Computer Science, Computer Engineering, Software Engineering
or other technical discipline (OR non-technical degree with 5 years of
experience in software engineering or software quality engineering
experience in addition to any other experience requirements)
Demonstrated understanding of product development
lifecycles, design change and document change control, process
verification and validation methodologies, and servicing in a medical
device environment
Demonstrated expertise to effectively communicate around
concepts of design controls; design verification and validation
activities; Corrective & Preventive Action (CAPA); complaints &
risk management; & product quality improvement using tools such as
six sigma, DFR, etc.
Software development or software engineering experience.
Professional certification such as ASQ – SQE, IEEE-SWEBOK, QAI-CQA
Demonstrated understanding of Medical Device QMS
requirements and regulatory requirements including but not limited to
FDA 21 CFR 820, IEC 62304-2006 (Medical Device Software), and ISO13485
Demonstrated knowledge of Quality Management Systems tools,
continuous improvement methodologies & in-depth understanding of
site level products & related processes
Excellent oral communication & report, business correspondence & procedure-writing skills
Analytical, problem solving & root-cause analysis skills
Ability to multi-task & handle tasks with competing priorities effectively
Change agent with energy, passion & enthusiasm to drive change
Demonstrated ability to communicate & implement a strategy under crisis situations to ensure compliance
Demonstrated experience using word processing, spreadsheet, and presentation software.
Demonstrated understanding of continuous quality / process improvement tools such as DMIAC, SPC, Lean, 5S
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