Clinical Product Surveillance Specialist-HC Job Job in Milwaukee, Wisconsin US
Clinical Product Surveillance Specialist-HC Job
The Clinical Product Surveillance Specialist (CPSS) 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. The CPSS also provides guidance to a cross-functional team on clinical scenarios and how to identify potentially hazardous situations in complaints. Essential Responsibilities Key responsibilities include: 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 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. Complete all planned Quality Compliance training within the defined deadlines 3. Zero repeat findings from previous internal and external audits within area of responsibility. 4. Assure complaints are closed per procedure and specific complaint closure date 5. Assure risk assessments meet GE Healthcare and regulatory requirements No late safety and regulatory reports to regulators Qualifications/Requirements: Bachelor's degree in medical science, heath sciences or healthcare related field and 2+ years of clinical experience; OR high school diploma/equivalency degree plus 6+ years of clinical experience Ability to quickly assess situations and make decisions Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment Ability to work independently in a team setting Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English (or local language) in an easy to understand manner Additional Eligibility Qualifications GE 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 background investigation and drug screen. Desired Characteristics Registered Nurse, CRNA Registered Radiologic Technologist (for positions supporting radiology-related businesses) Understanding of the clinical environment and product work flow Prior experience working with Microsoft office products (Word, Excel, PowerPoint) Nearest Major Market: Milwaukee Job Segments: CAPA, Clinic, Clinical Research, Compliance, Healthcare, Law, Legal, Management, Medical Research, Nursing, Quality, Quality Manager, Radiology, Registered Nurse