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 & 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 & 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 & 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 & 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 & 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