Senior Quality Assurance Engineer

Job Summary

A company is looking for an Engineer Sr. I - QA Design (Remote).

Key Responsibilities:

• Lead design assurance efforts for new product introduction projects, focusing on quality aspects of integrated software, electrical, and mechanical devices
• Ensure compliance with national and international regulations for electrical safety and environmental standards
• Facilitate verification/validation activities and lead product risk assessment activities using applicable standards and tools

Required Qualifications:

• Bachelor's degree in Engineering required; Biomedical, Mechanical, or Electrical Engineering preferred
• 5 years of design assurance or quality assurance experience in a medical device or highly regulated industry
• Working knowledge of ISO and FDA design and development quality requirements
• Experience in maintaining DHF & Technical File structure
• Basic knowledge of Electro-Medical safety standards and Risk Management for medical devices (per ISO 14971)