Software Quality Engineer

Three Point Solutions, Inc.

Boston, MA

Apply

JOB DETAILS

SALARY

$55–$60 Per Hour

SKILLS

Career Counseling, Coaching, Continuous Improvement, Contract Processing, Contract Requirements, Cross-Functional, Document Management, Documentation, Documentation Standards, Failure Mode and Effects Analysis (FMEA), Healthcare Software, International Electro-Technical Commission (IEC), Leadership, Maintain Compliance, Manufacturing, Medical Equipment, Mentoring, Microsoft Exchange Server, Problem Solving Skills, Process Control Engineering, Process Improvement, Product Reviews, Project Design, Project Management Software, Project/Program Management, Quality Engineering, Quality Management, Quality Metrics, Regulations, Regulatory Compliance, Risk Management, Risk Management Framework (RMF), Software Administration, Software Design, Software Development Lifecycle (SDLC), Software Engineering, Software Evaluation, Software Validation, System Validation, Test Plan/Schedule, Validation Testing

LOCATION

Boston, MA

POSTED

6 days ago

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

About the Company

Three Point Solutions, Inc.

At Three Point Solutions, we are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.

COMPANY SIZE

20 to 49 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2003

WEBSITE

http://www.3ptsolutions.com/