Job Description SummaryManages complaint handling activities and supports key Quality & Regulatory areas to ensure safe and effective products in the install base across GE Healthcare In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. 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

Uses product knowledge combined with skills in Product Surveillance to handle complaints, support regulatory reporting, and establish appropriate corrective and preventive actions for the safe and effective use of GE HealthCare (GEHC) Ultrasound products.

Evaluate complaints from patient safety perspective and identify complaints that require further evaluation according to global regulations, including 21CFR part 820.198, 803 (MDR), MDD/MDR, ISO 13485, etc.

Assess risk by providing guidance on clinical workflow and how products are used to identify potentially hazardous situations.

Manage risk by identifying product safety issues; triage complaints for further investigation

Responsible for hazard evaluations

Perform complaint closure according to set criteria and monitor through quality metrics

Ensures on time submissions of safety and regulatory reports to regulators

Provides objective evidence of complaint handling process through compliant documentation

Ensure zero repeat findings from previous internal and external audits within area of responsibility.

Support business during internal and external audits of GE Healthcare’s Quality Management System (QMS)

Develops knowledge of GEHC’s Quality Management System and Product Surveillance activities. Uses prior experience and acquired expertise to execute timely complaint handling process.

Applies general knowledge of how the Product Surveillance team contributes to other areas of the business developed through education or past experience.

Resolves issues using established procedures.

Consults People Leader or more senior team members for issues outside of defined parameters.

Collaborates with others to solve issues. 

Requests technical or clinical information from engineering, field service, clinical applications personnel, or end user/customer to solve issues.

Handles simple data entry work requiring face value check and correction.

Accountable for quality of own work and for meeting or exceeding the teams’ quality metrics

Continuously works on identifying opportunities to improve the complaint handling process

Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position

Complete all planned Quality & Compliance training within the defined deadlines

Identify and report any quality or compliance concerns and take immediate corrective action as required

Ability to communicate clearly in English, verbally and in writing

Required Qualifications

Bachelor's degree in Engineering from an accredited university or college with at least 2-4 years of experience in Engineering/ Quality and good knowledge of Ultrasound/Digital Products  

Desired Characteristics

GE HealthCare Product-specific knowledge

Medical Device industry experience preferred

Ability to demonstrate GEHC Growth Values

Ability to work independently & in a team setting

Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment

Excellent verbal, written, and presentation skills

Excellent interpersonal, organizational, time management skills

Familiarity with the application of medical device as it relates to patient safety

Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems

Ability to analyze and process data, and draw the appropriate conclusions

Prior experience working with Microsoft Office products.

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

Additional Information

Relocation Assistance Provided: No