Quality Engineer

Job Summary

A company is looking for a Quality Engineer to provide compliance support to the Regulatory Affairs organization.

Key Responsibilities

• Drive preparation of KPI dashboards and maintain oversight on formal RA management reviews and internal metrics
• Manage strategic programs for RA audit preparedness, including risk identification and mitigation
• Support quality system integration for acquisitions and new product introductions, and drive quality system process improvements

Required Qualifications

• Degree with 3+ years of experience in Regulatory Affairs & Quality Systems
• Hands-on exposure to medical device regulations (US FDA, CE) and QMS processes
• Experience with audit support and regulatory audit preparedness
• Strong program execution and compliance operations skills
• Able to independently manage multiple workstreams and drive process improvements