Medical Device Complaint Engineer

Job Summary

A company is looking for a Complaints Engineer - Medical Device.

Key Responsibilities

• Manage the complaint handling process for medical devices, ensuring adherence to regulatory standards
• Conduct investigations to determine root causes of complaints and ensure timely closure within established timelines
• Analyze complaint data to identify trends and collaborate with cross-functional teams for product improvement

Required Qualifications

• Bachelor's Degree in Engineering or a related scientific field
• 1-3 years of previous complaints experience required
• Experience in quality assurance and complaint handling
• Knowledge of relevant regulations (FDA, ISO 13485)
• Experience with root cause analysis tools and methodologies