Senior Staff, Software Quality Assurance Engineer

About the Role

Key Responsibilities

• Lead SOC 2 compliance activities and support internal and external audits.
• Define and update quality system software processes to ensure compliance with regulations related to change control, data privacy, software development, and security.
• Present product-related risks during design reviews and oversee mitigation throughout the product lifecycle.
• Influence new product development by defining design verification and validation test requirements to ensure compliance with design inputs and regulatory standards.
• Perform risk analyses and develop appropriate mitigation strategies.
• Collaborate with leadership and cross-functional teams to gather process requirements and drive continuous improvement.
• Conduct internal quality system audits and contribute to CAPA (Corrective and Preventive Action) initiatives.
• Work within Agile (Scrum)/DevOps environments using ALM tools for defect tracking, traceability, and release/build management.

Requirements

• Bachelor's degree in Software Engineering, Computer Science, or a related field.
• 6+ years of experience in software development or quality engineering roles.
• Working knowledge of the Software Development Life Cycle (SDLC) and proficiency in Agile, Scrum, SAFe, and DevOps methodologies.
• Experience with cloud platforms, preferably Microsoft Azure or AWS.
• Knowledge of SOC 2, ISO, HIPAA, FDA, or other related regulatory standards.
• Proficiency in Agile, Scrum, SAFe, and DevOps software development methodologies.
• Solid understanding of quality systems, including CAPA, audits, and statistical analysis.

Nice to Have

• Knowledge of AICPA SOC 2 certification requirements or equivalent standards.
• Familiarity with GAMP 5, Computer System Validation (CSV), and process validation.