Sr Software Quality Engr Exempt

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
Bachelors 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

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