QA Analyst - Remote
TradeJobsWorkForce92197 San Diego, CA, USQA Analyst Remote Job Duties: • Partner with the product and engineering team to understand project o... Show more
R&D Partners is seeking to hire a QA Complaint Intake Specialist in San Diego, CA . Your main responsibilities as a QA Complaint Intake Specialist: Receive complaint information from approved intake sources including Customer Support, field personnel, sales representatives, Medical Affairs, email communications, phone calls, and other authorized channels. Review incoming complaint information and supporting documentation to assess reported events, identify potential complaint criteria, and initiate required follow-up activities. Accurately document complaint information within the complaint handling module/eQMS. Perform initial complaint triage activities to assess completeness of available information, identify missing or unclear details, and determine the need for additional follow-up or escalation. Coordinate and document follow-up activities with internal and external stakeholders to obtain missing, incomplete, or clarifying information necessary for complaint assessment and investigation. What we are looking for in a QA Complaint Intake Specialist: Minimum 1-3 years of relevant experience in Quality Assurance, medical device/pharmaceutical documentation, customer support, or another regulated industry preferred. Medical device or pharmaceutical experience is preferred. BS/BA degree in a scientific, technical, healthcare, or quality-related discipline is desirable; equivalent experience may be considered. Experience with eQMS, complaint handling systems, or regulated documentation is preferred. The individual should have a basic understanding of medical device and quality system requirements; strong organizational skills; strong attention to detail; ability to accurately review and document information; ability to determine the number of complaint events from emails and supporting communications; ability to identify missing or unclear information; ability to coordinate timely follow-up; good written, verbal, and interpersonal communication skills; ability to work professorially with cross-functionally teams, Complainant, Customer Support, Field Sales, Medical Affairs, QA, Operations, and Complaint Investigators; ability to manage multiple complaint records within required timelines; and working knowledge of Microsoft Word, Excel, Outlook, and eQMS systems. Why Choose R&D Partners? As an employee, you have access to a comprehensive benefits package including: Medical insurance - PPO, HMO & 401k plan Employee Assistance Program Long-term disability Weekly payroll Online timecard approval R&D Partners is an equal-opportunity employer. #J-18808-Ljbffr
QA Complaint Intake Specialist • San Diego, CA, United States