Senior Complaint Specialist - Post-market surveillance (Req Medical Device Exp)

Senior Complaint Specialist - Post-market surveillance (Req Medical Device Exp) Location: San Diego, CA Duration: 3 Months Total Hours/week: 40.00 Shift: 1st Shift Client: Medical Devices Company Job Category: Clinical Level of Experience: Senior Level Employment Type: Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT) Job Description: The Sr. Complaint Specialist Investigation Lab role is responsible for medical device post‑market surveillance as it relates to complaint handling functions. Responsible for the completion of all tasks associated with complaint handling including investigation of failed product, working with hazardous materials in a controlled lab environment, writing clear and effective failure investigation reports, reviewing reported events in the complaints database for trending and optimal root cause identification, handling and properly dispositioning parts for investigation, and resolving issues. Provides technical expertise/troubleshooting for internal and external customers when requested. Duties & Responsibilities: Conduct product complaint investigations and write failure investigation reports. Ensure accuracy for complaint file documentation and regulatory reporting decision activities. Ensure complaint files are accurate, complete and in line with good documentation practices. Demonstrate sound independent decision making regarding medical device complaint handling and related investigations. Collaborate with supervisor, manager to assess the severity of complaints and understand typical use to provide input to technical investigations for optimal root cause resolution. Handle product for investigation per quality system requirements. In concert with department supervisor and/or manager and escalation teams, strategize to direct efforts to ensure dispensing customer satisfaction. Comply with FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Ensure timely follow-up with internal customers and company representatives for reported issues. Qualifications: Bachelor’s degree in a related field is desirable. 3-5 years of medical device experience is desired, preferably in a regulatory or technical complaint investigation capacity. 2+ years of experience with medical device complaint handling / post‑market surveillance or similar regulated environment preferred. Working knowledge of QA, Regulatory/Quality Compliance in a medical device industry preferred. Knowledge of electronics is preferred. Seniority level: Mid‑Senior level Job function: Information Technology Industries: Staffing and Recruiting Referrals increase your chances of interviewing at MillenniumSoft Inc by 2x #J-18808-Ljbffr MillenniumSoft Inc