Complaint Investigation

Location: San Diego, CA 92121 (Hybrid - 4 days onsite)Job Description SummaryThe Sr. Complaint Specialist Customer Advocacy role is responsible for medical device post-market surveillance as it relates to complaint handling functions. The role is responsible for the completion of all tasks associated with complaint handling including: investigation of failed product, working with hazardous materials in controlled lab environment, writing clear and effective failure investigation reports, review of reported events in the complaints database for trending and optimal root cause identification, assists in timely regulatory reporting (US – MDR and Canada MDPR), and resolving issues.

Additionally, provides technical expertise/troubleshooting for internal and external customers when requested. Education & Experience: Bachelor’s degree in related field is desirable5+ years of medical device experience is desired, preferably in a regulatory or technical complaint investigation capacity. Knowledge of the use of infusion pumps and disposable tubing equipment is desired but not necessary. 2+ years of experience with medical device complaint handling / post-market surveillance / medical device regulations or experience in a similar regulated environment preferred. Working knowledge of QA, Regulatory/Quality Compliance in a medical device industry preferred.