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.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Roles & 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 R&R, 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.
? Significant Multi-Modality Sites: Minimum 3 years Quality Assurance/Quality Engineering experience in the medical device or pharmaceutical industry Small and Simple Sites: Minimum 5 years Quality Assurance/Quality Engineering experience in other industry such as Motor/Electronics
? Demonstrated experience using word processing, spreadsheet, and presentation software.
Desired Characteristics
? Demonstrated understanding of continuous quality / process improvement tools:(As defined by the local site, e.g. DMAIC, SPC, Lean SS, 5S,)
? Ability to communicate using English

Inclusion and Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, ***, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
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.