Software Quality Engineer Visa Sponsorship Jobs in Massachusetts
Software quality engineer roles in Massachusetts are concentrated in the Greater Boston area, with major employers including MathWorks, HubSpot, Algolia, and biotech firms along the Route 128 corridor. The state's deep university pipeline and large tech sector make it one of the more active markets for visa sponsorship in this discipline.
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Get Access To All JobsJob Summary
The position is responsible to ensure that the Design Control and Risk Management activities throughout the product lifecycle are in compliance with procedures, standards and regulations applicable to our SaMD, SiMD and Digital products. This position provides project-level leadership, develops, applies and implements methods, tools and practices to achieve product quality and compliance goals and requirements in the areas of design, development, cybersecurity, verification and validation, maintenance and service.
Responsibilities
Key Accountabilities
- Provide software expertise, leadership, and direction throughout the software development lifecycle with a focus on appropriate and thorough testing.
- Function as a quality expert for all product development activities by ensuring compliance to applicable standards and regulations.
- Maintain up-to-date knowledge on cybersecurity requirements and provide leadership and guidance regarding implementation and compliance.
- Write, review and approve software release documentation and change orders.
- Provide leadership and guidance in software change control for defect tracking and resolution.
- Function as the quality expert in software risk management processes throughout the entire software lifecycle.
- Provide expertise in non-product software validation for software tools used in product manufacturing, product testing and the quality system.
- Provide software quality engineering expertise to relevant CAPAs and audits.
- Maintain up-to-date knowledge on software development tools and processes.
- Participate in the generation and review of Design History File and Risk Management documents throughout the product lifecycle.
- Advise and direct teams regarding compliance of software to procedures, standards and regulations including those related to cybersecurity and privacy requirements. Implement changes to procedures in alignment with evolving regulations.
- Participate on core teams supporting new product development or design changes.
- Defend relevant quality topics in audits and support corrective actions to improve and maintain compliance of the QMS.
- Interpret regulations and procedures to ensure documents are sound and defensible to auditors and regulatory bodies.
- Provide input on product requirements, acceptance criteria, traceability, product evaluation, failure investigation and complaint analysis.
- Work with Project Management, Development, Testing, Marketing, Regulatory, Service, Distribution, Sales & Marketing, and others outside the company (as needed) to recommend or prepare corrective / preventive actions (CAPA).
- May supervise the work of others.
- Lead cross-functional projects on technical and quality issues.
- Identify compliance gaps and suggest appropriate corrective actions as needed.
- Support internal and external audits.
- Lead quality system improvement projects as required.
Networking / Key Relationships
- Manufacturing/Operations
- Manufacturing Engineering
- Regulatory Affairs
- Research & Development
- Service
Qualifications
Minimum Knowledge & Experience required for the position:
- Bachelor's of Science degree plus a minimum of 12 years related experience or Master's Degree plus a minimum of 9 years related experience or waiver based on experience.
- ASQ SQE certification preferred.
- Additional experience working in or knowledge of:
- Software Engineering Platforms and Applications (Cloud-Based Preferred)
- Project design, validation, quality plans and risk management (including human factors and Cybersecurity)
- Preparing submissions, complaint systems and/or authorities reporting activities
- AI/ML models (desirable)
- Solid knowledge and experience working with medical device international regulations (FDA QSR, EU Medical Device Regulation, etc.) and related standards (ISO 13485, ISO 14971, IEC 62304, IEC 62366, TIR 57, etc.)
- Language: English
Skills & Capabilities
The ideal candidate for this position will exhibit the following skills and capabilities:
- Deep knowledge of domestic and international quality/regulatory standards related to both Software in and Software as a Medical Device products (21 CFR Part 820, 21 CFR Part 11, ISO 13485, IEC 62304).
- Demonstrates nuanced judgment commensurate with experience regarding application of regulatory requirements to data review, reports, design changes, risk management, etc. to ensure compliance and achieving business objectives. Demonstrated understanding of risk based approach to processes and decisions.
- Broad and thorough knowledge of engineering and science theory and principles, including R&D, quality control, manufacturing and design engineering.
- Understanding of the application of technical principles and engineering problem solving to resolve complex issues.
- Membership on external standards organizations of industry groups with influence of our products – desirable.
- Advanced understanding of software Development Life Cycle Models.
- Advanced understanding of Software Configuration Management (SCM).
- Strong understanding of risk management and risk management tools (ISO 14971 & TIR 24971).
- Advanced understanding of software development and testing processes.
Travel Requirements
Approximately 15% of time
Job Summary
The position is responsible to ensure that the Design Control and Risk Management activities throughout the product lifecycle are in compliance with procedures, standards and regulations applicable to our SaMD, SiMD and Digital products. This position provides project-level leadership, develops, applies and implements methods, tools and practices to achieve product quality and compliance goals and requirements in the areas of design, development, cybersecurity, verification and validation, maintenance and service.
Responsibilities
Key Accountabilities
- Provide software expertise, leadership, and direction throughout the software development lifecycle with a focus on appropriate and thorough testing.
- Function as a quality expert for all product development activities by ensuring compliance to applicable standards and regulations.
- Maintain up-to-date knowledge on cybersecurity requirements and provide leadership and guidance regarding implementation and compliance.
- Write, review and approve software release documentation and change orders.
- Provide leadership and guidance in software change control for defect tracking and resolution.
- Function as the quality expert in software risk management processes throughout the entire software lifecycle.
- Provide expertise in non-product software validation for software tools used in product manufacturing, product testing and the quality system.
- Provide software quality engineering expertise to relevant CAPAs and audits.
- Maintain up-to-date knowledge on software development tools and processes.
- Participate in the generation and review of Design History File and Risk Management documents throughout the product lifecycle.
- Advise and direct teams regarding compliance of software to procedures, standards and regulations including those related to cybersecurity and privacy requirements. Implement changes to procedures in alignment with evolving regulations.
- Participate on core teams supporting new product development or design changes.
- Defend relevant quality topics in audits and support corrective actions to improve and maintain compliance of the QMS.
- Interpret regulations and procedures to ensure documents are sound and defensible to auditors and regulatory bodies.
- Provide input on product requirements, acceptance criteria, traceability, product evaluation, failure investigation and complaint analysis.
- Work with Project Management, Development, Testing, Marketing, Regulatory, Service, Distribution, Sales & Marketing, and others outside the company (as needed) to recommend or prepare corrective / preventive actions (CAPA).
- May supervise the work of others.
- Lead cross-functional projects on technical and quality issues.
- Identify compliance gaps and suggest appropriate corrective actions as needed.
- Support internal and external audits.
- Lead quality system improvement projects as required.
Networking / Key Relationships
- Manufacturing/Operations
- Manufacturing Engineering
- Regulatory Affairs
- Research & Development
- Service
Qualifications
Minimum Knowledge & Experience required for the position:
- Bachelor's of Science degree plus a minimum of 12 years related experience or Master's Degree plus a minimum of 9 years related experience or waiver based on experience.
- ASQ SQE certification preferred.
- Additional experience working in or knowledge of:
- Software Engineering Platforms and Applications (Cloud-Based Preferred)
- Project design, validation, quality plans and risk management (including human factors and Cybersecurity)
- Preparing submissions, complaint systems and/or authorities reporting activities
- AI/ML models (desirable)
- Solid knowledge and experience working with medical device international regulations (FDA QSR, EU Medical Device Regulation, etc.) and related standards (ISO 13485, ISO 14971, IEC 62304, IEC 62366, TIR 57, etc.)
- Language: English
Skills & Capabilities
The ideal candidate for this position will exhibit the following skills and capabilities:
- Deep knowledge of domestic and international quality/regulatory standards related to both Software in and Software as a Medical Device products (21 CFR Part 820, 21 CFR Part 11, ISO 13485, IEC 62304).
- Demonstrates nuanced judgment commensurate with experience regarding application of regulatory requirements to data review, reports, design changes, risk management, etc. to ensure compliance and achieving business objectives. Demonstrated understanding of risk based approach to processes and decisions.
- Broad and thorough knowledge of engineering and science theory and principles, including R&D, quality control, manufacturing and design engineering.
- Understanding of the application of technical principles and engineering problem solving to resolve complex issues.
- Membership on external standards organizations of industry groups with influence of our products – desirable.
- Advanced understanding of software Development Life Cycle Models.
- Advanced understanding of Software Configuration Management (SCM).
- Strong understanding of risk management and risk management tools (ISO 14971 & TIR 24971).
- Advanced understanding of software development and testing processes.
Travel Requirements
Approximately 15% of time
Software Quality Engineer Job Roles in Massachusetts
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Search Software Quality Engineer Jobs in MassachusettsSoftware Quality Engineer Jobs in Massachusetts: Frequently Asked Questions
Which companies sponsor visas for software quality engineers in Massachusetts?
Massachusetts-based employers with consistent H-1B sponsorship histories for software quality engineers include MathWorks in Natick, HubSpot and Wayfair in Boston, and a range of biotech and medtech companies along the Route 128 corridor. Large tech contractors and defense firms such as Raytheon also appear in Department of Labor LCA disclosure data for this role type.
Which visa types are most common for software quality engineers in Massachusetts?
The H-1B is the most common visa category for software quality engineers in Massachusetts, as the role typically qualifies as a specialty occupation requiring a bachelor's degree in computer science, software engineering, or a related field. Candidates already holding TN status (Canadian or Mexican nationals), O-1B, or L-1B visas may also find employers willing to maintain or transfer those classifications depending on their background.
How to find software quality engineer visa sponsorship jobs in Massachusetts?
Migrate Mate filters job listings specifically by visa sponsorship and role, so you can browse software quality engineer openings in Massachusetts without sorting through positions that don't offer sponsorship. The platform surfaces employers who have active sponsorship histories for this role in the state, which is more useful than searching general job boards where sponsorship status is rarely disclosed upfront.
Which cities in Massachusetts have the most software quality engineer sponsorship jobs?
Boston has the highest concentration of software quality engineer sponsorship jobs in Massachusetts, particularly in the Seaport District and Cambridge, where major tech companies and startups cluster. Natick, Waltham, and Burlington along Route 128 are also significant hubs, driven by enterprise software firms and biotech companies with established engineering teams and international hiring programs.
Are there any Massachusetts-specific considerations for software quality engineers seeking visa sponsorship?
Massachusetts sets its own prevailing wage determinations through the Department of Labor's OFLC process, and the Boston metro area generally carries higher prevailing wage levels than national averages for software quality engineers. The state's concentration of research universities, including MIT and Northeastern, creates a strong OPT-to-H-1B pipeline, meaning many employers in the area already have established processes for sponsoring international engineering candidates.
What is the prevailing wage for sponsored software quality engineer jobs in Massachusetts?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.
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