Job Description Summary

Manages complaint handling activities and supports key Quality & Regulatory areas to ensure safe and effective products in the install base across GE Healthcare Developing conceptual knowledge of professional discipline. May include support roles with specialized expertise or technical knowledge in broad area.

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:

• Ensure customer communications are created and issued; review customer responses for technical accuracy related to GE HealthCare products.

• Evaluate complaints from patient safety perspective and identify complaints that require further evaluation under 21CFR part 803 (MDR).

• Responsible for hazard evaluations.

• Follow-up with the end user / customer.

• Participate in complaint investigations, CAPA and proper complaint closure according to set criteria.

• Analyze data on patient safety and risk, ensuring compliance with applicable post market regulations.

• Manage risk by identifying product safety issues, triage complaints for further investigation.

• Applies general knowledge of business developed through education or past experience. Understands how work of own team contributes to the area.

• 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. For customer facing roles, develops strong customer relationships and serves as the interface between customer and GEHC. Exchanges technical information asks questions and checks for understanding.

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

Quality Specific Goals:

• 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.

• Ensure timely complaint handling and reporting.

• Ensure that safety and regulatory reports to regulators are not late.

• Assure complaints are closed per procedure and specific complaint closure date.

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

• Provide objective evidence of complaint handling process through compliant documentation.

Required Qualifications:

• Bachelor's degree in medical science, health sciences or healthcare related field and a minimum of 2 years of clinical experience; OR high school diploma/equivalency degree plus a minimum of 6 years of clinical experience.

Desired Characteristics:

• Product-specific knowledge - Ultrasound.

• Registered Ultrasound Technologist.

• Demonstrated knowledge of 21CFR Part 820.

• Ability to demonstrate GEHC Growth Values.

• Understanding of the clinical environment and product workflow.

• Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment.

• Ability to work independently & in a team setting.

• Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English (and where appropriate, be able to communicate in the local language verbally and in writing).

• Excellent interpersonal, organizational, and influencing skills.

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

• Ability to analyze and process data and draw the appropriate conclusions.

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

• Prior experience working with Microsoft Office products.

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.

#LI-DRJ

#LI-Hybrid

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