Certified Software Quality Engineer Lead

Job Summary

Leading a team of software quality engineers, the full-time Certified Software Quality Engineer Lead will manage medical device software projects remotely, ensuring compliance with regulatory requirements and overseeing the verification and validation processes.

Key responsibilities

• Manage direct reports and oversee software project deliverables to ensure compliance with local procedures and regulatory standards
• Provide leadership in the establishment of software requirements, specifications, and validation protocols while collaborating with project teams
• Support internal and external audits and implement necessary changes to maintain the effectiveness of the quality management system

Required qualifications

• Bachelor's degree in Computer Science, Engineering, or a related field
• 8 years of experience in Software Quality Engineering or a related occupation
• Certified Software Quality Engineer (CSQE) certification
• Project Management Professional (PMP) certification
• Experience with global ISO standards and regulatory requirements for medical devices