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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 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 skills in post market product surveillance to handle complaints and support efforts for regulatory reporting and establishing appropriate corrective and preventive actions for the safe and effective use of GE HealthCare (GEHC) products.

• 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.

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

• Evaluate complaints from patient safety perspective and identify complaints that require further evaluation under 21CFR part803 (MDR)

• Responsible for hazard evaluations

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

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

• Analyze data on patient safety and risk, ensuring compliance with applicable postmarket regulations

Quality Specific Goals

• Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, QualityGoals, 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

• Bachelors degree in engineering or health sciences field; or a High School diploma/GED and minimum 2 years work experience in a Quality or Regulatory Assurance related field

Desired Characteristics

• Minimum 1 year experience in medical device or pharmaceutical industry in an Engineering, Quality or Regulatory related role

• GE HealthCare Product-specific knowledge - Ultrasound

• CFR Demonstrated knowledge of ISO 13485

• 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 with the ability to communicate business issues clearly in English (and whereappropriate, 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

• 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.

Additional Information

Relocation Assistance Provided: No