Job Description
Software Quality Engineer
Job Description
We are seeking a Senior Software Quality Engineer with extensive experience in supporting regulated medical devices. This role involves managing verification and validation activities across software, firmware, and hardware systems to ensure compliance with FDA and international standards.
Responsibilities
+ Execute Verification and Validation (V&V) activities for Class II and Class III medical devices.
+ Develop and maintain test plans, protocols, and reports in compliance with FDA 21 CFR 820 and IEC standards.
+ Perform system-level, integration, and safety-critical testing for embedded systems.
+ Conduct risk analysis and support Corrective and Preventive Actions (CAPA) activities.
+ Collaborate cross-functionally with R&D, Systems, Manufacturing, and Regulatory teams.
+ Support audits and regulatory inspections through well-documented quality artifacts.
+ Contribute to ...
Job Description
We are seeking a Senior Software Quality Engineer with extensive experience in supporting regulated medical devices. This role involves managing verification and validation activities across software, firmware, and hardware systems to ensure compliance with FDA and international standards.
Responsibilities
+ Execute Verification and Validation (V&V) activities for Class II and Class III medical devices.
+ Develop and maintain test plans, protocols, and reports in compliance with FDA 21 CFR 820 and IEC standards.
+ Perform system-level, integration, and safety-critical testing for embedded systems.
+ Conduct risk analysis and support Corrective and Preventive Actions (CAPA) activities.
+ Collaborate cross-functionally with R&D, Systems, Manufacturing, and Regulatory teams.
+ Support audits and regulatory inspections through well-documented quality artifacts.
+ Contribute to ...