Summary

As a Senior Quality Engineer, you will provide quality engineering process support to GE HealthCare digital products in accordance with GE HealthCare medical device Quality Management System (QMS). You will be responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business. You will work hands-on with quality and compliance activities around Software Development Projects.
At GE Healthcare, our machines, our software, our solutions, our services, and our people make a genuine difference to medical professionals and patients all over the world. That’s because we never lose sight of what healthcare really needs—the human touch.

Roles and Responsibilities:

• 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).
• Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
• 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.
• 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 digital medical devices, including design reviews, processes/practices simplification, quality system training, etc.

Required Qualifications:

• Minimum 5 years’ experience in Quality Assurance / Regulatory Affairs.
• Minimum 3 years’ experience in software within a regulated industry.
• Bachelor's Degree in Engineering, Computer Science or equivalent.

Desired Characteristics:

• Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
• Previous project management experience.
• Experience in a global working environment.
• Demonstrate technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.
• Experience leading and implementing change. Experience performing internal audits and participating in external audits.
• Practical knowledge of software development and familiarity with Software Development Lifecycle (SDLC), design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies in medical device or healthcare software development environment.
• Demonstrated expertise with effectively communicating 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.
• Demonstrate experience with Agile/Lean software development methods.

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 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.

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While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.