Quality Assurance Specialist – Medical Devices

Summary:

Seeking a Device Quality Assurance Specialist with experience in medical device quality systems to support the creation, management, and maintenance of Device Quality Management System (QMS) records while ensuring compliance with FDA and international regulatory standards.

Key Responsibilities:

• Manage Device QMS records including complaints, deviations, CAPAs, change controls, and audits
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485:2016, and EU MDR
• Support quality documentation, procedures, and continuous improvement initiatives
• Track and report device quality metrics for management review

Requirements:

• Bachelor’s degree in Science or related field
• 3–5 years of experience in a medical device or regulated industry
• Strong knowledge of 21 CFR Part 820 and ISO 13485
• Strong analytical and communication skills