Quality Specialist

Job Summary

A company is looking for a Quality Specialist-Post Market to manage product complaints and ensure compliance with regulatory standards.

Key Responsibilities

• Evaluate and determine reportability of complaints in accordance with regulatory standards
• Perform and coordinate complaint investigations, ensuring thorough analysis and timely escalation of issues
• Maintain complaint logs and participate in process improvements related to quality and regulatory duties

Required Qualifications

• Bachelor's Degree or Associate Degree in science, technology, or medical fields
• 3-5 years of experience in Quality Assurance or complaint processing roles
• Previous experience in medical devices with knowledge of ISO 13485 and FDA regulations
• Basic knowledge of Quality Systems such as CAPA and non-conformances is a plus
• Experience with software/firmware complaints is an advantage