Responsibilities

• Receive and review complaints related to medical devices
• Investigate complaints by gathering information, analyzing data, and conducting root cause analysis
• Communicate directly with customers to address concerns and provide updates
• Serve as a liaison between Therapy Support and Quality departments
• Ensure complaint investigations are complete, accurate, and closed in a timely manner
• Collaborate with cross-functional teams including Regulatory and Product
• Ensure compliance with FDA 21 CFR Part 820 and ISO 13485
• Prepare for and participate in internal and external audits
• Contribute to cross-functional process improvement initiatives

Requirements

• Bachelor’s degree in biomedical engineering, life sciences, or related area (or equivalent experience)
• 2+ years of experience in an FDA-regulated environment
• 3+ years of experience communicatin...