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Job Description Summary

As a Design Quality Engineer, you will develop and implement compliance strategies to support New Product Introductions (NPI) and Installed Base (IB) projects for a large MR design center within the areas of design, design transfer, manufacturing, and service.

As a critical member of the NPI core team you will ensure adherence to the GE HealthCare Quality Management System and regulatory requirements (e.g. 21 CFR 820, ISO 13485, MDSAP). By employing strong critical thinking and influencing skills you will work cross functionally to ensure robust quality decisions. In this role, you will have a direct impact on ensuring patient safety, audit readiness and execution, and enable commercial delivery of GE HealthCare MR systems.

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.

Job Description

Roles and Responsibilities

• Creates a Quality culture by driving compliance activities for a large MR design center. Develops and implements compliance strategies to support New Product Introductions (NPI) and Installed Base (IB) projects within the areas of design, design transfer, manufacturing, service.

• Ensures compliance to GE HealthCare QMS and regulatory requirements (e.g. 21 CFR 820, ISO 13485, MDSAP) while driving process effectiveness and efficiency. Ensures plans, protocols, results, and conclusions are generated, reviewed, and approved according to applicable procedures.

• Performs internal audits, for example assessing compliance of the Design History File (DHF) and other program files, to ensure quality standards and regulatory requirements are addressed.

• Responsible QA for CAPA projects (Corrective and Preventive Action), including root cause investigations and nonconformance evaluations.

• Maintains product and site certifications through successful external audits. Drives audit readiness activities and may represent GE HealthCare to external agencies during audits.

• Applies Lean methodologies to improve daily work and simplify processes.

Required Qualifications

• Bachelor's degree from an accredited university or college (OR a high school diploma / GED with at least 6 years of relevant work experience).

• At least 3 years of relevant experience in Quality Assurance in a regulated industry, e.g. Medical Devices.

• Demonstrated understanding of Medical Device Quality Management System 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. Sponsorship for employment visas for this job opening, now or in the future, is not available.

Desired Characteristics

• Quality Assurance/Quality Engineering experience in the Medical Device/Pharmaceutical industry OR experience in Design Engineering or Manufacturing Engineering in the Medical Device field.

• Demonstrated expertise in Medical Device Design Controls, Production and Process Controls, and Installation and Servicing.

• Skilled influencer who is able to communicate clearly regarding Design Controls, Design Verification and Validation, Production and Process Controls, Corrective & Preventive Action (CAPA), and Risk Management.

• Demonstrated collaboration and conflict management skills.

• Ability to lead, develop, communicate, and implement a strategy under crisis to ensure compliance.

• Exceptional critical thinking, problem solving, root-cause analysis, and process improvement skills.

• Ability to effectively manage execution of tasks with competing priorities.

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Additional Information

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.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 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