Job Description Summary
Manages investigational activities and supports key areas to ensure safe and effective medical products in new products and the installed base across GE Healthcare MICT products. This includes the analysis of complaints, review of trends, ownership of investigations to determine root causes and proposal of possible solutions. Additional tasks are the ongoing required maintenance of such investigations for design changes and periodic reviews. The role includes close work with internal interfaces such as engineering teams, production, service, quality assurance and regulatory.
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
You will own investigations as a result of complaint trending alerts that exceed threshold.This requires defining containment, establishing a team, and leading investigational activities to determine potential root causes.You will review complaint and field data, use problem solving tools, and partner with global engineering team across MICT to determine and implement appropriate corrective and preventive actions for the safe and effective use of GE HealthCare (GEHC) products
Work with NPI design engineering team during product development to determine if program scope contains new potential reasons for failure and the residual risk. Based on this, update/add investigation codes to existing investigation documents. The evaluation of new codes requires technical evaluation of impact using risk mitigation tools such as failure models and effects analysis (FMEA)
Own and maintain root cause investigation matrix documents on a routine basis in accordance with evolving trends identified in complaint data, to ensure problem codes can be tied to low impact complaints.
Conduct periodic reviews of aforementioned investigations to determine the need to update them based on product data, design changes, or field feedback
Identify trends from complaint data that can support activities that consider both the business and the technical needs of the customers with the goal of providing a quality product that meets the users needs (such as IFR90 reduction, CSO resolution/elimination, etc).
Required Qualifications
This role requires experience in the Engineering/Technology & Operations. Knowledge level is comparable to a Bachelor’s degree from an accredited university or college.
Demonstrated execution at meeting project goals while satisfying quality, performance, and schedule.
Has ability to use judgement to analyze and process data and draw the appropriate conclusions to address matters of technical variety.
Uses technical experience and analytical thinking.
Uses multiple internal and limited external sources outside of own teams to arrive at decisions.
Desired Characteristics
Knowledge of Risk Management (FTA, FMEA, Risk Assessment Control)
Recognized ability to work in a multifunctional manner in order to be able to interact in particular with teams (Engineering, Manufacturing, Services, Quality, Certification, Regulatory, Sourcing)
Proven ability to produce results while working on multiple projects at once, balancing resources, time and quality of results
Excellent problem-solving skills, team player.
Desired Knowledge of Medical Imaging Systems
Ability to work with global teams and cultures, including time-zone flexibility
Experience working in a regulated environment
Fluent oral and written English
Inclusion and Diversity
GE Healthcare is an Equal Opportunity Employer where inclusion matters. 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.
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.
Disclaimer: GE HealthCare will never ask for payment to process documents, refer you to a third party to process applications or visas, or ask you to pay costs. Never send money to anyone suggesting they can provide employment with GE HealthCare. If you suspect you have received a fraudulent call , please fill out the form below: https://www.ge.com/careers/fraud
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Additional Information
Relocation Assistance Provided: No
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