Senior Software Quality Engineer

Software Quality Responsibilities

• Develop, implement, and maintain comprehensive software quality assurance strategies, plans, and procedures in accordance with industry best practices and regulatory requirements (e.g., FDA, ISO 13485, IEC 62304).
• Lead review from Quality perspective for design, development, and execution of comprehensive test plans, test cases, and automation scripts for complex software systems, including embedded, application, and cloud-based solutions.
• Lead and/or defect management to review and disposition project defects
• Lead and participate in design reviews, code reviews, and other technical assessments to identify potential quality issues early in the development process.
• Understanding of test plans, test cases, and test scripts for various levels of testing, including unit, integration, system, and regression testing.
• Perform risk analysis and develop mitigation strategies for software defects and quality-related issues.
• Perform root cause analysis for software defects and collaborate with development teams to implement effective corrective and preventive actions.
• Drive continuous improvement initiatives in software quality processes, tools, and metrics, leveraging industry standards (e.g., ISO 13485, IEC 62304, FDA 21 CFR Part 820).
• Understanding of complaint handling process, metrics and product risk assessment
• Collaborate closely with software development, project management, and regulatory affairs teams to ensure seamless integration of quality activities throughout the product lifecycle.
• Investigate, analyze, and document software defects, working with development teams to ensure timely resolution and verification.
• Participate in external and internal audits, providing documentation and expertise related to software quality.
• Stay current with emerging technologies, industry trends, and regulatory changes in medical device software quality.
• Provide technical leadership and mentorship to junior quality engineers, fostering a culture of quality and continuous learning.
• Investigate corrective actions associated with nonconforming product and customer complaints.
• Collaborates with other functional teams to identify, investigate and resolve quality issues, including containment, disposition and escalation actions
• Performs supplier audits (as leader, when qualified) or assists the audit leader per the audit schedule.
• Prepares supplier audit reports and manages supplier corrective actions.

General Duties

• Participates in third party and internal quality audits involving areas of responsibility.
• Establishes, maintains Standard Operating Procedures and Forms related to areas of responsibility.
• Advises and trains other Company personnel concerning areas of responsibility.
• Communicates information related to quality management system effectiveness.
• Works in accordance with quality system procedures.

Salary Range: $90K - $150K