Job Information
GE Healthcare Program Manager, NPI Quality, MR Design Quality Engineer in Waukesha, Wisconsin
Job Description Summary
Join our team as a Design Quality Engineer, where you will play a pivotal role in developing and implementing compliance strategies for New Product Introductions (NPI) and Installed Base (IB) projects at our MR Innovation Center. Your responsibilities will span across design and development, 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, including 21 CFR 820, ISO 13485, and 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 the 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
Foster a culture of quality by leading compliance activities at our MR Innovation Center. Develop and implement compliance strategies to support New Product Introductions (NPI) and Installed Base (IB) projects across design and development, design transfer, manufacturing, and service.
Ensure adherence to GE HealthCare’s Quality Management System (QMS) and regulatory requirements, including 21 CFR 820, ISO 13485, and MDSAP. Drive process effectiveness and efficiency by ensuring that plans, protocols, results, and conclusions are generated, reviewed, and approved according to applicable procedures.
Perform internal audits to ensure QMS requirements and regulatory requirements are addressed.
Oversee Corrective and Preventive Action projects, as Responsible QA, ensuring quality decisions, robust root cause investigations and nonconformance evaluations.
Maintain product and site certifications through successful external audits. Lead audit readiness activities and represent GE HealthCare during external audits.
Apply Lean methodologies to solve problems, 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 5 years of relevant experience to Quality Assurance in a regulated industry, either Medical Devices or Pharmaceuticals.
Demonstrated understanding of Medical Device Quality Management System requirements and regulatory requirements including but not limited to FDA CFR 21 820, ISO 13485, and MDSAP.
Legal authorization to work in the U.S. is required. Sponsorship for employment visas, now or in the future, for this job opening is not available.
Desired Characteristics
Experience in Quality Assurance or Quality Engineering within the Medical Device or Pharmaceutical industry, or 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.
Experience with applying the GE HealthCare Quality Management System in New Product Introduction programs.
Strong influencing skills and ability to clearly communicate the requirements of Design Controls, Design Verification and Validation, Production and Process Controls, Corrective & Preventive Action (CAPA), and Risk Management across functions.
Demonstrated ability to collaborate effectively and resolve conflicts.
Capability to lead, develop, communicate, and implement compliance strategies during crises.
Exceptional critical thinking, problem solving, root-cause analysis, and process improvement skills.
Excellent interpersonal and leadership abilities.
Proficiency in managing multiple priorities effectively.
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.
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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