QA Engineer Job in Issaquah 98027, Washington US


Business Segment
Healthcare Life Sciences

About Us
GE Healthcare’s Life Sciences business delivers breakthroughs in tools for drug discovery and biopharmaceutical manufacturing and the latest in cellular technologies, enabling scientists and specialists around the world to discover new and better ways to predict, diagnose and treat disease earlier. The Life Sciences business also makes systems and equipment for the purification of biopharmaceuticals.
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 a $17 billion unit of General Electric Company (NYSE: GE), employing more than 46,000 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. GEHC-LS

Role Summary/Purpose
The Quality Assurance Engineer is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. The Quality Assurance Engineer is responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business.

Essential Responsibilities
• Responsible for ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility. • 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, including but not limited to Six Sigma, Lean Manufacturing, 5S, SPC, engineering studies, DOE, Gauge RR, etc. • Ensures process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans, including Master Validation Plans (Site Level), Validation Master Plans (Product or Process specific plans), and the development of simple yet detailed process flow diagrams that describe critical process interdependencies with respect to process inputs, outputs, risks and impacts. • 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. • Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.

Qualifications/Requirements

  • Bachelor’s degree (or high school diploma/GED plus 4 years working experience in Quality Engineering or Quality Assurance Management)
  • 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 understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment
  • Minimum 3 years Quality Assurance/Quality Engineering experience in the medical device or pharmaceutical industry
  • Demonstrated experience using word processing, spreadsheet, and presentation software.
  • Demonstrated understanding of continuous quality / process improvement tools:(As defined by the local site, e.g. DMIAC, SPC, Lean SS, 5S,)
  • Able to travel up to 20% of the time

    Desired Characteristics

  • Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies in-depth understanding of site level products related processes
  • 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; product quality improvement using tools such as six sigma, DFR, etc.
  • Experience with procedure development and process mapping
  • Understanding of ISO9001 coupled with auditing certification and/or experience
  • Supplier management and qualification experience

    GE is an equal opportunity employer, offering a great work environment, challenging career opportunities, professional training and competitive compensation.