Quality Engineer - SaMD

Job Description Summary

No sponsorship for this role*

The Caption Health SBU focuses on clinical applications that aid in early disease detection, using AI to assist in conducting ultrasound scans. Caption Care is a turnkey, end-to-end echo program that leverages Caption AI technology platform to deliver convenient, cost-effective echocardiograms in any care setting to identify heart disease earlier-before undiagnosed issues become serious.

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.

Job Description

No sponsorship for this role*

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.

• Minimum 3 years' experience in software within a regulated industry.

• ?Demonstrate 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.

• 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 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.

• Demonstrate technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.

For U.S. based positions only, the pay range for this position is $82,400.00-$123,600.00 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

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (~~~) . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

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.

Relocation Assistance Provided: No

Application Deadline: July 29, 2024