Quality Engineer Visa Sponsorship Jobs in Massachusetts
Massachusetts quality engineer roles are concentrated in the state's life sciences corridor, with major employers like Boston Scientific, Raytheon Technologies, and Thermo Fisher Scientific regularly hiring internationally. The Greater Boston area, including Cambridge and Woburn, along with the Route 128 technology belt, anchor most visa sponsorship activity for quality engineering positions in the state.
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Get Access To All JobsJob Summary
We are seeking a Design Quality Engineer to act as the primary quality liaison to R&D, ensuring compliance with medical device design control regulations across both software and hardware development. This role will play a critical part in maintaining design quality, risk management, and regulatory compliance throughout the product lifecycle.
Key Responsibilities
- Serve as Quality liaison to R&D teams for design and development activities
- Ensure compliance with:
- ISO 13485 (Quality Management System)
- IEC 62304 (Medical Device Software Lifecycle)
- ISO 14971 (Risk Management)
- Review and approve Design History File (DHF) deliverables
- Participate in design and phase reviews
- Ensure adherence to design control processes for software & hardware
- Review supplier/component qualification records
- Lead and facilitate:
- Hazard Analysis
- FMEA (Failure Modes & Effects Analysis)
- Fault Tree Analysis
- Maintain and update Risk Management File (RMF)
- Review and approve Engineering Change Notices (ECNs)
- Ensure completeness and compliance of:
- DHF (Design History File)
- DMR (Device Master Record)
- DHR (Device History Record)
Required Experience
- 10+ years in Medical Device Quality / Design Assurance
- Strong experience in design controls for both software & hardware
- Hands-on experience with:
- DHF documentation
- Risk management (ISO 14971)
- Software lifecycle compliance (IEC 62304)
- Experience supporting R&D teams during product development
Key Skills
Strong knowledge of:
- Design controls & regulatory requirements
- Risk analysis tools (FMEA, Fault Tree, Hazard Analysis)
Ability to:
- Review technical documentation critically
- Work cross-functionally with engineering teams
- Strong attention to detail and documentation accuracy
Job Summary
We are seeking a Design Quality Engineer to act as the primary quality liaison to R&D, ensuring compliance with medical device design control regulations across both software and hardware development. This role will play a critical part in maintaining design quality, risk management, and regulatory compliance throughout the product lifecycle.
Key Responsibilities
- Serve as Quality liaison to R&D teams for design and development activities
- Ensure compliance with:
- ISO 13485 (Quality Management System)
- IEC 62304 (Medical Device Software Lifecycle)
- ISO 14971 (Risk Management)
- Review and approve Design History File (DHF) deliverables
- Participate in design and phase reviews
- Ensure adherence to design control processes for software & hardware
- Review supplier/component qualification records
- Lead and facilitate:
- Hazard Analysis
- FMEA (Failure Modes & Effects Analysis)
- Fault Tree Analysis
- Maintain and update Risk Management File (RMF)
- Review and approve Engineering Change Notices (ECNs)
- Ensure completeness and compliance of:
- DHF (Design History File)
- DMR (Device Master Record)
- DHR (Device History Record)
Required Experience
- 10+ years in Medical Device Quality / Design Assurance
- Strong experience in design controls for both software & hardware
- Hands-on experience with:
- DHF documentation
- Risk management (ISO 14971)
- Software lifecycle compliance (IEC 62304)
- Experience supporting R&D teams during product development
Key Skills
Strong knowledge of:
- Design controls & regulatory requirements
- Risk analysis tools (FMEA, Fault Tree, Hazard Analysis)
Ability to:
- Review technical documentation critically
- Work cross-functionally with engineering teams
- Strong attention to detail and documentation accuracy
Quality Engineer Job Roles in Massachusetts
See all 421+ Quality Engineer Jobs in Massachusetts
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Search Quality Engineer Jobs in MassachusettsQuality Engineer Jobs in Massachusetts: Frequently Asked Questions
Which companies sponsor visas for quality engineers in Massachusetts?
Life sciences and defense manufacturers drive most quality engineer sponsorship in Massachusetts. Companies like Boston Scientific, Raytheon Technologies, Thermo Fisher Scientific, Hologic, and Insulet Corporation have consistent hiring patterns for international quality engineers. Large semiconductor and medical device employers along the Route 128 corridor file H-1B petitions regularly, as quality assurance functions require specialized technical degrees that support specialty occupation classification.
Which visa types are most common for quality engineer roles in Massachusetts?
The H-1B is the most common visa for quality engineers in Massachusetts, as roles requiring a degree in engineering, materials science, or a closely related field typically satisfy the specialty occupation standard. Candidates from Australia may qualify for the E-3 visa, and Canadian or Mexican nationals may qualify under the TN category using the engineer classification. Some employers also support O-1 petitions for candidates with documented technical distinctions.
Which cities in Massachusetts have the most quality engineer sponsorship jobs?
Greater Boston, including Cambridge and Woburn, accounts for the largest share of quality engineer sponsorship positions in Massachusetts, driven by its concentration of medical device, biotech, and defense employers. Marlborough, Waltham, and Natick along the Route 128 corridor also host significant manufacturing and hardware operations. Worcester has a growing advanced manufacturing base, and Lowell supports electronics and semiconductor quality roles.
How to find quality engineer visa sponsorship jobs in Massachusetts?
Migrate Mate filters job listings specifically by visa sponsorship availability, making it easier to identify Massachusetts quality engineer roles where employers have indicated willingness to sponsor. Rather than sorting through thousands of general postings, you can focus on life sciences, defense, and advanced manufacturing employers in Greater Boston and the Route 128 corridor who actively file H-1B petitions for quality engineering positions.
Are there any Massachusetts-specific factors quality engineers should know about visa sponsorship?
Massachusetts is home to a dense university pipeline, including MIT, Northeastern, and UMass Amherst, that feeds quality engineering talent into local employers. This means sponsoring companies are accustomed to international candidates and often have established immigration counsel. The state's concentration of FDA-regulated medical device and pharmaceutical manufacturers means quality engineers frequently work in GxP environments, and job descriptions tend to specify degree fields precisely, which directly affects specialty occupation eligibility determinations.
What is the prevailing wage for sponsored 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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