JOB REQUIREMENTS: Essential Duties and Responsibilities * Supports internal and external quality system audits. * Supports various elements of the Quality Management System, including: * * Incoming product inspections * * Nonconforming product system, including testing, in-market actions, and re-work. * * Complaints and post market surveillance, including product evaluations. * * Tracking service complaints and assisting with the device servicing record closure * * Corrective/preventative action (CAPA), including sampling. * * General Quality System Procedural Maintenance and projects * Assists in developing and maintaining written procedures, work instructions, and other QMS documentation as required to define and ensure conformance to customer and regulatory requirements. * Performs inspection of customer returned products and collaborates with cross-functional teams to ensure accurate and timely complaint investigations. Routine problem-solving to establish root cause of respective complaints. * Complete complaint investigations and product evaluations in a timely manner. Reviews complaint supporting records including production records to ensure accurate complaint investigations, establishing root cause for respective complaints, trend reviews, country reporting criteria, risk file reviews. * Completes Medical Device Record Decision trees within 48 hours of receipt and prepares electronic submissions for internal approval. * Tracking bed servicing complaints and attaching respective DHRs to the servicing complaint records. Performing due diligence and following up when necessary. * Escalates serious complaints to management in a timely manner. Participates in Corrective and Preventative Action Activities ensuring the appropriate product feedback loop is closed. * Performs routine analysis of post-market data and reports results to management. Including active complaint monitoring on amazon and other social media sources. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function. An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. The above list reflects the general details necessary to describe the principle and essential functions of the position and shall not be construed as the only duties that may be assigned for the position. Core Values & Guiding Principles * Understands internal and external customers * Assure a safe work environment * Encourage individual development * Demonstrates teamwork and flexibility/adaptability * Demonstrates honesty * Keep our commitments * Think systemically and ensure... For full info follow application link. TIDI Products is an Equal Opportunity Employer - Minorities/Females/Veterans/Disabled are encouraged to apply ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/1DA6FD428ACE4251