Quality Engineer I

Job Summary

A company is looking for a Quality Engineer I, remote position focused on supporting product development and ensuring compliance with quality standards.

Key Responsibilities

• Lead activities to support new product development and existing products/processes
• Ensure compliance with quality system requirements and engage in risk management and design control activities
• Collaborate with cross-functional teams to analyze post-market metrics and develop continuous improvement projects

Required Qualifications

• B.S. in Engineering, Science, or Statistics
• Minimum of 5 years of experience in product development and quality within a medical device environment
• Minimum of 3 years of experience in developing and improving product development processes
• Experience with quality system design related to design control or risk management processes (ISO 14971)
• Proficiency in medical device GxP ISO Standards and demonstrated experience in product/process/system validations