Sr. Complaint Specialist Investigation Lab - Onsite

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 and complete and in line with good documentation practices
• Demonstrate sound independent decision making in regard to medical device complaint handling and other functions relating to the investigation of product complaints
• Collaborate with supervisor, manager to assess the severity of complaints and understand the typical use to provide input to the Technical investigation for optimal root cause resolution as needed
• Handle product for investigation per quality system requirements
• In concert with the department supervisor and/or manager and escalation teams, strategize to direct the efforts to ensure Dispensing customer satisfaction

Qualifications

• Bachelor’s degree in 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 / medical device regulations or experience in a similar regulated environment preferred
• Working knowledge of QA, Regulatory/Quality Compliance in a medical device industry preferred
• Knowledge of electronics is preferred