Sr Software Quality Engineer/Pay rate : $63/hr.

$63 per hour

LanceSoft Inc

Job Description

Job Summary:

Seeking a Sr Software Quality Engineer to support medical device software and system development within a regulated environment. The ideal candidate will have strong software engineering knowledge along with experience in design controls, software risk management, and verification & validation .

Key Requirements:

5+ years of relevant experience in Software Quality, Software Engineering, Systems Engineering, or Design Assurance.
Bachelor's or master's degree in engineering or related technical field.
Hands-on software coding experience with C, C++, Java, Python , or similar.
Strong experience with Software Risk Assessment/Risk Management .
Experience with Software Verification & Validation (V&V) .
Knowledge of Design Controls, requirements traceability, and software lifecycle activities .
Medical device or other regulated-industry experience preferred.
Knowledge of IEC 62304, ISO 14971, ISO 13485, and FDA design control requirements is a plus.
Strong communication and cross-functional collaboration skills.

Responsibilities:

Provide quality oversight throughout the software/system development lifecycle.
Support software requirements, design reviews, risk assessments, and V&V activities.
Ensure compliance with applicable quality and regulatory requirements.
Partner with Engineering, Quality, Regulatory, Clinical, and Product Development teams.
Support root cause analysis, corrective actions, and continuous improvement.

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Vacancy posted 6 days ago

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