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Cypress HCM · San Diego, California
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
Details
| Company | Cypress HCM |
| Location | San Diego, California |
| Type | FULL TIME |
| Niche | Computer and Mathematical Occupations |
| Salary | $90,000 – $90,000 / yr |