Job Summary

The Quality Assurance Engineer is responsible for ensuring product and process compliance with Quality Management System (QMS) requirements and applicable regulatory standards. The role supports manufacturing, verification, validation, documentation review, nonconformance management, and continuous improvement activities for complex electromechanical medical devices.

Key Responsibilities

• Review manufacturing, testing, and inspection records to ensure compliance with QMS requirements.
• Perform quality review and approval of Device History Records (DHR/eDHR), protocols, reports, and engineering documentation.
• Support Nonconformance (NC), CAPA, deviation, and change control activities.
• Participate in product verification, validation, and process qualification activities.
• Review rework documentation and manufacturing records.
• Ensure compliance with FDA, ISO 13485, and company quality procedures.
• Support internal, customer, and regulatory audits.
• Collaborate with Manufacturing, R&D, Supply Chain, and Operations teams.
• Develop and maintain quality metrics and dashboards.
• Prepare and review quality procedures, work instructions, and validation documentation.

Skill Requirements

• Bachelor's degree in Engineering, Quality, Manufacturing, Biomedical, Mechanical, or related field.
• 3–5 years of Quality Engineering or Quality Assurance experience in a regulated industry.
• Experience with Quality Management Systems (QMS).

Other Requirements