Clinical Product Surveillance Specialist

Job description

3201418
Additional Cities

Milwaukee
Career Level

Experienced
Relocation Assistance

No
Business

GE Healthcare
Business Segment

Healthcare Quality
Function

Quality
Country/Territory

United States
Additional States/Provinces

Wisconsin
Postal Code

53223-3219
Role Summary/Purpose

Uses knowledge of clinical workflow and product use in assessing incoming complaints and the hazards they may contain as well as assisting in determining postmarket reportability. Provides guidance to a cross-functional team on clinical scenarios and how to identify potentially hazardous situations in complaints.
Essential Responsibilities

1. Evaluate complaints from patient safety perspective and identify complaints that require further evaluation under 21CFR part 803 (MDR)2. Responsible for hazard evaluations3. Participate in Risk Assessments4. Ensure customer communications are created and issued; review customer responses for technical accuracy related to GE products5. Follow-up with the end user / customer6. Participate in complaint investigations, CAPA and proper complaint closure according to set criteria7. Analyze data on patient safety and risk, ensuring compliance with applicable postmarket regulations8. Manage risk by identifying product safety issues; triage complaints for further investigation
Qualifications/Requirements

1. Bachelor's degree in medical science, heath 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

1. Product-specific knowledge 2. Registered Nurse or CRNA or Registered Radiologic Technologist3. Demonstrated knowledge of 21CFR Part 8204. Ability to demonstrate GEHC Growth Values5. Understanding of the clinical environment and product work flow6. Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment7. Ability to work independently & in a team setting 8. 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).9. Excellent interpersonal, organizational, and influencing skills 10. Familiarity with the application of medical device as it relates to patient safety11. Ability to analyze and process data, and draw the appropriate conclusions12. Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems13. Ability to analyze and process data, and draw the appropriate conclusions14. Prior experience working with Microsoft Office products15. Working knowledge of GEHC products
About Us

GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers. www.ge.com
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is anEqual Opportunity Employer . 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.
Additional Eligibility Qualifications

GE will only employ those who are legally authorized to work in the United States for this opening.
Primary Country

United States
Primary State/Province

Wisconsin
Primary City

Milwaukee