Software Quality Engineer

Job Title: Software Quality Engineer Client: Medical Device Manufacturing Industry Duration: 5 Months (possible extension) Location: Boston, MA 02210 Shift: 1st Shift Role Overview Lead and maintain software quality standards, methods, and procedures Ensure compliance with regulatory and contractual requirements Support full software lifecycle from design to implementation Operate independently with limited supervision Manage or lead projects related to software quality Top Technical Skills Performing Software FMEA Risk Management Planning and Reporting Knowledge of IEC 62304 Key Responsibilities Develop, modify, and maintain software quality standards and procedures Evaluate software activities including requirements, design, development, testing, and validation Define quality measures to ensure product compliance Establish operating criteria for software quality programs Ensure documentation complies with project, process, and contract requirements Review software design and change specifications against requirements Verify software requirements for traceability and testability Maintain software quality documentation across all lifecycle stages Deliver and manage assigned quality projects Work with cross-functional stakeholders to achieve results Act as mentor or lead for lower-level professionals Quality and Compliance Duties Conduct verification and validation of software systems Review specifications, tools, techniques, and methodologies Ensure process control documentation meets regulatory standards Support continuous improvement of quality systems Identify and resolve complex quality issues Recommend process and system improvements Project and Leadership Duties Manage projects from design through implementation Coach and review work of junior specialists Delegate tasks and review work products Build consensus to meet team and project objectives Communicate with senior internal and external stakeholders Communication and Collaboration Exchange information on project status, risks, and issues Influence decision making through quality recommendations Coordinate with vendors and external partners Support training and coaching within job area Tools and Standards IEC 62304 Software FMEA Risk Management frameworks Quality Management Systems Project management tools Required Skills Advanced knowledge of software quality engineering Strong analytical and problem-solving skills Experience with project management concepts Ability to work independently Strong documentation and review skills Education and Experience Bachelor's degree required Minimum 4 years of relevant experience OR advanced degree with minimum 2 years of relevant experience Role Scope Responsible for full software quality lifecycle Handles complex and multi-disciplinary quality issues Supports regulatory compliance for medical device software Drives process, system, and product improvements Leads or manages quality-related projects #ZR Software, Quality, devolop