GE HealthCare Quality Engineer - SaMD 

Remote, Remote 

228205971

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.

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.

Application Deadline: April 03, 2025