Senior Quality Engineer

Job Summary

A company is looking for a Senior Quality Engineer to join their Quality and Regulatory Affairs team.

Key Responsibilities:

• Support software releases through risk assessments and process improvements for risk management
• Collaborate with cross-functional teams to manage quality project activities and audits
• Provide input to the risk management process and support Quality System management and CAPA processes

Required Qualifications:

• Bachelor's degree in science, engineering, or equivalent
• 6-8 years of experience in the medical device industry focused on Quality
• Experience with software as a medical device, particularly in AI and ML
• High competency in ISO 13485, ISO 14971, and 21 CFR 820
• Certified Quality Auditor is a plus