Complaint Investigation Specialist (MDR)

Job Title: Complaint Investigation Specialist (MDR)

Pay Rate: $40 to $45.44/hr

Duration: 12 months

Location: Irvine, CA

We are looking for a Complaint Investigation Specialist (MDR) to assess complaint information provided, evaluate each event for determination if it qualifies as a complaint, and escalate as appropriate

• Manage customer relationships and expectations during the course of the complaint investigation and resolution process
• Research, seek information and input, and challenge as appropriate, from Product Safety, Engineering, and other departments/business units for complaint investigations
• Identify problems and lead projects to improve processes, procedures, and/or practices; recommend solutions, including devising new approaches to problems encountered
• Evaluate complaints for Medical Device Reporting (MDR); prepare and submit MDR reports to the FDA
• Summarize findings, including a review of the investigation, product analysis, imaging review, instructions for use (IFU), and any other relevant labeling and/or training materials, and formulate conclusions
• Prepare and submit final customer correspondence
• Assist in planning agendas and running weekly meetings to discuss complaint issues with affected functions (e.g., Manufacturing, Quality Assurance, Suppliers, etc.) to identify assignable root cause, resolve open action items, and gather additional technical information to resolve complaints

Requirements:

• Bachelor's Degree or equivalent in a related field
• 2-4 years of experience required
• Full knowledge of Medical Device Reporting regulations and regulatory reporting regulations
• Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing
• Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment is required