Clinical Product Surveillance Specialist
Posted 3/8/2019 3:52:48 AM
Job Function: Quality
Business Segment: Healthcare Quality
Location(s): United States; Wisconsin; Milwaukee
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.
Evaluate complaints from patient safety perspective and identify complaints that require further evaluation under 21CFR part 803 (MDR)
Responsible for hazard evaluations
Participate in Risk Assessments
Ensure customer communications are created and issued; review customer responses for technical accuracy related to GE products
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 postmarket regulations
Manage risk by identifying product safety issues; triage complaints for further investigation
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
Registered Nurse or CRNA or Registered Radiologic Technologist
Demonstrated knowledge of 21CFR Part 820
Ability to demonstrate GEHC Growth Values
Understanding of the clinical environment and product work flow
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 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
GE Healthcare provides transformational medical
technologies and services to meet the demand for increased access, enhanced quality and more affordable
healthcare around the world. GE works on things that matter - great people and technologies taking on tough
challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery,
biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps
medical professionals deliver great healthcare to their patients.
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GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.
Locations: United States; Wisconsin; Milwaukee
GE will only employ those who are legally authorized to work in the United States for this opening.