General Electric Lead Quality Engineer in Chicago, Illinois
Job Description Summary
As the Lead Quality Engineer, you are responsible for upholding and implementing the GE Healthcare Quality Policy & Quality Management System for GE Healthcare Digital and the Chicago site.
You will support medical device software teams in frequent design and development activities with direct customer, commercial, and business impact. You will provide QMS process support in accordance with documented procedures and practices in order to ensure patient safety, reduce regulatory risk, and enable commercial delivery of GE Healthcare Digital products. You are responsible for the implementation and continuous improvement of established quality compliance practices.
GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. 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 and Responsibilities
Create a Quality culture by driving compliance activities for GEHC Digital medical device software products and the Chicago site.
Ensure ongoing patient safety, regulatory compliance, and enable commercial delivery of GE Healthcare Digital products by providing total quality management system process support. in accordance with documented procedures and practices.
Responsible for implementing and continuously improving the total quality management system. Ensures quality and regulatory compliance while driving process effectiveness and efficiency.
Ensures projects/products meets or exceeds customer expectations, product quality targets, and global regulatory requirements related to software.
Champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting, and operating mechanisms.
Performs internal audits, supports external audits, and promotes product and process improvements through root cause analysis and CAPA.
Performs a broad variety of tasks in support of medical device software teams over the product lifecycle, as assigned by the site quality manager.
Explains information; developing skills to bring team members to consensus around total quality and continuous improvement.
Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 4 years of experience).
Minimum of 2 years of related work experience
Experience in software design & development and/or understanding of product software development lifecycles, software design change and document change control, software process verification and validation methodologies, and servicing in a medical device environment.
Experience in a Regulated Industry and/or demonstrated understanding of Medical Device quality management system, regulatory, and software development requirements including but not limited to FDA 21 CFR 820, EN 62304, and ISO 13485.
Demonstrated expertise to effectively communicate within all levels of an organization around concepts of software design controls, Corrective & Preventive Action (CAPA), complaints, risk management, and product quality.
Strong oral and written communication skills.
Demonstrated ability to analyze and resolve problems.
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.
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer (https://assets.phenompeople.com/CareerConnectResources/GE11GLOBAL/en_global/desktop/assets/images/poster_screen_reader_optimized_w_supplement.pdf) . 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 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).
As a federal government contractor, GE requires U.S. employees to be fully vaccinated against COVID-19 unless you receive an approved medical or religious accommodation. Proof of vaccination will be required.
Relocation Assistance Provided: No