Job Description Summary

Executes complaint handling activities and supports key Quality & Regulatory areas to ensure safe and effective products in the install base across GE Healthcare.

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:

• Key contributor as part of a complaint handling unit. Evaluating product complaints for safety, product quality, regulatory compliance and escalating for further action as required.

• Implementing methods and procedures for effective trending of complaints.

• Facilitating complaint investigation.

• Engaging product design owners to determine effective CAPA.

• Identifying complaints that represent further evaluation under 21CFR Part 803 (MDR).

• Reviewing appropriate criteria for closure of complaints.

• Owning and communicating metrics on complaint closure status.

• Continuously working to improve the complaint handling process.

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.

• Evaluate, close, and trend complaints in alignment with applicable Complaint Handling Procedures

• 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.

• Identify and report any compliance gaps

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

• Timely complaint handling and reporting.

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

Required Qualifications:

• Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 2 years of experience in Quality or Regulatory Assurance / Engineering / Service).

Desired Characteristics:

• Product specific knowledge in X-Ray, Invasive Cardiology, or Bone Mineral Density medical devices.

• Working knowledge of GEHC products

• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes.

• Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.

• Demonstrated knowledge of 21CFR Part 820.

• Ability to work independently & in a team setting.

• Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English

• 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.

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

• 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-MC2

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