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Role Summary: 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 evaluations
3. Participate in Risk Assessments
4. Ensure customer communications are created and issued; review customer responses for technical accuracy related to GE products
5. Follow-up with the end user / customer
6. Participate in complaint investigations, CAPA and proper complaint closure according to set criteria
7. Analyze data on patient safety and risk, ensuring compliance with applicable postmarket regulations
8. Manage risk by identifying product safety issues; triage complaints for further investigation
Qualifications/Requirements: Quality Specific Goals:
1. 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
2. Experience working with Cardiology equipments, like EKG Machines, Defibrillators or Monitors
Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required
4. Ensure timely complaint handling and reporting
5. Ensure that safety and regulatory reports to regulators are not late
6. Assure complaints are closed per procedure and specific complaint closure date
7. Ensure zero repeat findings from previous internal and external audits within area of responsibility.
8. Assure risk assessments meet GE Healthcare and regulatory requirements
9. Provide objective evidence of complaint handling process through compliant documentation
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
2. Registered Nurse or CRNA or Application Specialist.
3. Demonstrated knowledge of 21CFR Part 820
4. Ability to demonstrate GEHC Growth Values
5. Understanding of the clinical environment and product work flow
6. Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment
7. 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 safety
11. Ability to analyze and process data, and draw the appropriate conclusions
12. Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
13. Ability to analyze and process data, and draw the appropriate conclusions
14. Prior experience working with Microsoft Office products
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