GLAUKOS – QUALITY SOFTWARE ENGINEER II (SAN CLEMENTE, CA)

How will you make an impact?
Glaukos is a leading medical device and pharmaceutical company, committed to transforming healthcare through groundbreaking products and services. We are seeking a highly skilled Quality Software Engineer II, specialized in GxP systems, to join our team and ensure that our software solutions for medical devices and pharmaceutical products adhere to the highest quality and regulatory standards.

• Develop, implement, and maintain the software quality assurance program for GxP systems in medical device and pharmaceutical products, in accordance with industry standards, regulatory requirements, and company guidelines.
• Collaborate with cross-functional teams, including software development, project management, and regulatory affairs, to ensure quality objectives are met throughout the software development lifecycle.
• Review and approve software documentation for GxP systems, including requirements, design specifications, test plans, and test results, to ensure compliance with applicable regulations and standards.
• Design, execute, and analyze test cases to verify that the GxP systems meet defined requirements and identify defects or deviations from expected performance.
• Conduct root cause analysis of software defects in GxP systems and collaborate with the development team to implement corrective and preventive actions.
• Monitor, analyze, and report on GxP system software quality metrics, such as defect density, test coverage, and pass/fail rates, to identify trends and areas for improvement.
• Participate in internal and external software quality audits, as well as regulatory inspections, as needed.
• Support continuous improvement initiatives by identifying opportunities to enhance GxP system software quality processes and methodologies.
• Provide guidance and training to team members on GxP system software quality assurance best practices and regulatory requirements.
• Stay informed on industry trends, new technologies, and regulatory changes to ensure continued compliance and competitiveness in the medical device and pharmaceutical market.