Quality Assurance Specialist Jobs in USA with Visa Sponsorship
Quality Assurance Specialists qualify for H-1B visa, E-3 visa, and TN visa sponsorship when the role requires a bachelor's degree in computer science, engineering, or related technical field. QA roles involving test automation, compliance frameworks, or specialized industry knowledge (healthcare, finance, aerospace) have stronger visa approval odds than general manual testing positions. For detailed occupation requirements, see the O*NET profile.
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Get Access To All JobsINTRODUCTION
Are you passionate about ensuring compliance and patient safety in the medical device industry? At Hologic, we are seeking a Clinical QA Specialist to play a critical role in the investigation and reporting of potential and actual adverse events, as well as other regulatory reporting activities. In this role, you’ll collaborate with cross-functional teams, including Technical Service, Marketing, Sales, and Regulatory, to ensure timely and thorough documentation, analysis, and reporting. If you thrive in a fast-paced, collaborative environment and have a strong background in regulatory compliance and quality assurance, this is your opportunity to make a meaningful impact on healthcare innovation.
ROLE AND RESPONSIBILITIES
Knowledge:
- Comprehensive understanding of FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, and ISO 14971 for risk management.
- Strong knowledge of medical procedures and the expected and potential outcomes related to Hologic’s product portfolio.
- Familiarity with post-market surveillance requirements, adverse event reporting, and health risk assessments.
- Awareness of regulatory reporting processes, including MedWatch reports, notified body communications, and external notifications.
Skills:
- Proven ability to independently collect, analyze, and assess information associated with adverse events and determine appropriate next steps.
- Effective communication skills to interact with internal teams, sales personnel, customers, patients, and regulatory agencies.
- Strong organizational skills to ensure timely documentation, reporting, and follow-up of adverse events and regulatory submissions.
- Analytical skills to support and lead investigations, including CAPAs, nonconformances, and other quality system processes.
- Experience in developing metrics and quality reports related to reportable events and identifying potential excursions.
- Ability to innovate and improve processes to enhance efficiency and compliance with post-market surveillance requirements.
- Proficient in leading or participating in internal and external audits, inspections, and assessments.
Behaviors:
- Proactive and detail-oriented, ensuring compliance with regulatory requirements and internal procedures.
- Collaborative and team-oriented, fostering strong relationships across functions to support investigations and reporting activities.
- Customer-focused, ensuring communications and responses are timely, accurate, and aligned with patient safety goals.
- Resilient and adaptable, thriving in a fast-paced and evolving environment.
- Problem-solving mindset, with a commitment to driving resolution and continuous improvement in quality processes.
BASIC QUALIFICATIONS
- Bachelor’s degree in Medicine, Nursing, Biomedical Engineering, Electromedical Engineering, or a related field. Risk Managers will also be considered.
- 5+ years of experience in a similar role, preferably within the medical device or healthcare industry.
- Hands-on experience with adverse event reporting, regulatory communications, and health risk assessments.
- Proven track record in supporting or leading CAPAs, nonconformances, and quality investigations.
WHY JOIN Hologic?
We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
The annualized base salary range for this role is $83,000 - $129,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.
Agency and Third-Party Recruiter Notice
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
INTRODUCTION
Are you passionate about ensuring compliance and patient safety in the medical device industry? At Hologic, we are seeking a Clinical QA Specialist to play a critical role in the investigation and reporting of potential and actual adverse events, as well as other regulatory reporting activities. In this role, you’ll collaborate with cross-functional teams, including Technical Service, Marketing, Sales, and Regulatory, to ensure timely and thorough documentation, analysis, and reporting. If you thrive in a fast-paced, collaborative environment and have a strong background in regulatory compliance and quality assurance, this is your opportunity to make a meaningful impact on healthcare innovation.
ROLE AND RESPONSIBILITIES
Knowledge:
- Comprehensive understanding of FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, and ISO 14971 for risk management.
- Strong knowledge of medical procedures and the expected and potential outcomes related to Hologic’s product portfolio.
- Familiarity with post-market surveillance requirements, adverse event reporting, and health risk assessments.
- Awareness of regulatory reporting processes, including MedWatch reports, notified body communications, and external notifications.
Skills:
- Proven ability to independently collect, analyze, and assess information associated with adverse events and determine appropriate next steps.
- Effective communication skills to interact with internal teams, sales personnel, customers, patients, and regulatory agencies.
- Strong organizational skills to ensure timely documentation, reporting, and follow-up of adverse events and regulatory submissions.
- Analytical skills to support and lead investigations, including CAPAs, nonconformances, and other quality system processes.
- Experience in developing metrics and quality reports related to reportable events and identifying potential excursions.
- Ability to innovate and improve processes to enhance efficiency and compliance with post-market surveillance requirements.
- Proficient in leading or participating in internal and external audits, inspections, and assessments.
Behaviors:
- Proactive and detail-oriented, ensuring compliance with regulatory requirements and internal procedures.
- Collaborative and team-oriented, fostering strong relationships across functions to support investigations and reporting activities.
- Customer-focused, ensuring communications and responses are timely, accurate, and aligned with patient safety goals.
- Resilient and adaptable, thriving in a fast-paced and evolving environment.
- Problem-solving mindset, with a commitment to driving resolution and continuous improvement in quality processes.
BASIC QUALIFICATIONS
- Bachelor’s degree in Medicine, Nursing, Biomedical Engineering, Electromedical Engineering, or a related field. Risk Managers will also be considered.
- 5+ years of experience in a similar role, preferably within the medical device or healthcare industry.
- Hands-on experience with adverse event reporting, regulatory communications, and health risk assessments.
- Proven track record in supporting or leading CAPAs, nonconformances, and quality investigations.
WHY JOIN Hologic?
We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
The annualized base salary range for this role is $83,000 - $129,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.
Agency and Third-Party Recruiter Notice
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
See all 454+ Quality Assurance Specialist jobs
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Get Access To All JobsTips for Finding Visa Sponsorship as a Quality Assurance Specialist
Emphasize Technical Complexity
Highlight automated testing frameworks, API testing, performance testing tools, and programming languages. Manual-only QA roles face higher scrutiny for specialty occupation requirements under visa regulations.
Target Industry-Specific QA Roles
Healthcare, financial services, and aerospace QA positions requiring regulatory compliance knowledge (FDA, SOX, FAA) demonstrate clear specialty occupation qualifications for visa sponsorship applications.
Focus on Enterprise Software Companies
Large software companies with complex products regularly sponsor QA specialists. They understand the technical expertise required and have established visa sponsorship processes and legal resources.
Highlight Security Testing Experience
Cybersecurity testing, penetration testing, and vulnerability assessment skills strengthen visa applications. These specialized areas require advanced technical knowledge beyond basic functional testing capabilities.
Document Degree-Role Connection
Prepare examples showing how your computer science, engineering, or IT degree directly applies to QA methodologies, testing frameworks, and technical problem-solving in your target role.
Consider QA Lead or Senior Positions
Leadership roles involving team management, process design, or tool selection demonstrate higher-level responsibilities that support specialty occupation arguments in visa petition filings.
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Find Quality Assurance Specialist JobsFrequently Asked Questions
What degree do I need for QA visa sponsorship?
A bachelor's degree in computer science, software engineering, information technology, or a related technical field is typically required. Some employers accept degrees in mathematics, physics, or engineering if combined with relevant QA experience. The degree must directly relate to the technical aspects of quality assurance work.
Do manual testing roles qualify for H-1B sponsorship?
Manual-only QA roles face higher scrutiny and lower approval rates. USCIS expects specialty occupation roles to require technical expertise beyond basic clicking and following test scripts. Focus on positions involving test automation, API testing, performance testing, or industry-specific compliance knowledge to strengthen your case.
Which QA specializations have the best sponsorship prospects?
Test automation engineers, security testers, performance testing specialists, and QA roles in regulated industries (healthcare, finance, aerospace) have stronger sponsorship prospects. These positions require specialized technical knowledge and tools that clearly demonstrate specialty occupation requirements for visa approval.
Can I get sponsored as a QA contractor or consultant?
Yes, but the sponsoring company must be your actual employer, not the end client. Consulting firms that specialize in QA services often sponsor visas for permanent employees they place at client sites. Direct contractor relationships typically don't qualify for traditional employment-based visa sponsorship.
How to find Quality Assurance Specialist jobs with visa sponsorship?
To find Quality Assurance Specialist jobs with visa sponsorship, use Migrate Mate, which specializes in connecting international candidates with sponsoring employers. Focus your search on tech companies, software development firms, and large corporations that frequently sponsor H-1B, TN, and other work visas for QA professionals. These employers value QA specialists' technical skills in testing methodologies, automation tools, and quality processes.
What if my degree isn't in computer science?
You can still qualify through the three-for-one rule where three years of relevant work experience substitutes for one year of education. A two-year degree plus six years of progressive QA experience, or twelve years of experience without a degree, may meet the requirements depending on the role's complexity.
What is the prevailing wage requirement for sponsored Quality Assurance Specialist jobs?
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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