Engineer II, Software Quality Assurance

Job Summary

The Software Quality Assurance (SWQA) Engineer II provides quality and compliance support for medical device software development programs. This role partners with cross-functional teams to ensure software products are developed, verified, validated, and maintained in accordance with company procedures, regulatory requirements, and industry standards. Responsibilities include software design controls, risk management, verification and validation reviews, change assessments, and quality oversight throughout the product lifecycle.

Key Responsibilities

• Provide Quality Assurance support for software development and sustaining engineering projects.
• Review software lifecycle deliverables including requirements, design documentation, traceability artifacts, verification and validation protocols/reports, and release documentation.
• Participate in software risk management activities, including hazard analysis, risk assessments, and verification of risk controls.
• Review software verification and validation activities to ensure appropriate coverage, traceability, and objective evidence.
• Support Software Change Assessments (SCA), impact assessments, CAPA, remediation, and post-market quality activities.
• Partner with R&D, Systems Engineering, Regulatory Affairs, and Program teams to ensure compliance with software design control requirements.
• Support compliance with applicable standards and regulations, including IEC 62304, ISO 13485, ISO 14971, and FDA QSR.
• Participate in continuous improvement initiatives and support audit readiness activities.

Required Qualifications

• Bachelors degree in Computer Science Engineering, Software Engineering, or equivalent.
• 3+ years of experience in Software Quality, Software Development, Software Verification & Validation, or related engineering function.
• Knowledge of Software Development Lifecycle (SDLC) processes.
• Strong analytical, problem-solving, and communication skills.
• Ability to work effectively in a cross-functional environment.

Preferred Qualifications

• Experience in a regulated industry such as Medical Devices, Healthcare, Aerospace, or Automotive.
• Knowledge of IEC 62304, ISO 13485, ISO 14971, and FDA Design Controls.
• Experience with software design controls, risk management, and software validation.
• Familiarity with Agile development methodologies and lifecycle management tools such as Windchill, Jira.
• Exposure to cybersecurity, CAPA, remediation, or post-market quality activities.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.