Quality Engineer - SaMD

Job Description SummaryThe GE HealthCare Ultrasound segment, a fast-growing business in GE HealthCare, is the global leader in ultrasound medical devices and solutions. The portfolio spans the continuum of care to enable customers with ultrasound screening, diagnosis, treatment and monitoring of diseases. Our customers are seeking to improve efficiency in radiology and beyond and increase user confidence to provide better clinical outcomes. Consequently, the need for AI, digital solutions, and automation, connecting devices and software in one seamless ecosystem continues to proliferate. The Caption Health SBU focuses on clinical applications that aid in early disease detection, using AI to assist in conducting ultrasound scans.
The Quality Engineer provides quality engineering process support to GE HealthCare digital products in accordance with GE HealthCare medical device Quality Management System (QMS). They are 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.
 

Job Description

In this role you will:

• Guide teams in creating software development plans, design change plans, design inputs, verification and validation plans and reports, risk management documentation, defect resolution, SDLC deliverables, design reviews, non-product software validation.
• Participate in core teams as the quality representative, and review and approve program documentation.
• Ensure program compliance to GE work instructions and applicable regulations such as ISO 13485, ISO 14971, IEC 62304, 21 CFR Part 820, MDD, MDR.
• Support nonconformance evaluations, investigations, CAPA action plans, effectiveness checks.
• Participate in internal audits and support internal and external audits.
• Perform other duties as assigned.

Basic Qualifications:

• Bachelor’s degree in engineering, computer science, or equivalent.
• Minimum 3 years’ experience in Quality Assurance/Regulatory Affairs.
• Experience in software within a regulated industry.
• Must be willing to travel as required.
• Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening. 

Desired Characteristics:

• 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 experience with Agile/Lean software development methods.
• Previous project management experience.
• Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
• 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.
• Experience in a global working environment.
• Experience leading and implementing change. Experience performing internal audits and participating in external audits.
• Demonstrated technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.

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.

For U.S. based positions only, the pay range for this position is $84,800.00-$127,200.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

Additional Information

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.

Application Deadline: April 24, 2025