Job Summary

A company is looking for a Design Quality/Risk Management Engineer with strong risk management and remediation experience in the Life Sciences & Technology industry.

Key Responsibilities:

• Review risk management files for Design History File (DHF) and execute documents at a high level
• Perform tactical change notices, drawing updates, design change deliverables, post market surveillance document review and approval, and risk assessments
• Improve and maintain the current state of risk management files

Required Qualifications:

• 7+ years of experience in design quality and risk management
• Experience with DHF and understanding of risk management
• Experience with Class II and III disposable medical devices is preferred
• Ability to work independently and handle change requests
• Degree in a related field is required