H-1B Visa QA Engineer Jobs
QA Engineer roles qualify as H-1B visa specialty occupations because they require a bachelor's degree in computer science, software engineering, or a related field. Employers file a Labor Condition Application with DOL before sponsoring you, certifying the role meets prevailing wage requirements for your work location.
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Get Access To All JobsINTRODUCTION
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic individual to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities
- Perform on-the-floor Plant Quality Assurance (PQA) review and approval of cGMP manufacturing processes, procedures, testing methods, documents, and production records.
- Review and approve batch records, MES/EBR, SAP, EDMQ, DQMS, and TrackWise documentation, including deviations, CAPAs, and validations.
- Ensure deviations and quality events are properly triaged, investigated, documented, and resolved in accordance with procedures and cGMP requirements.
- Review and assess changes for potential impact to product quality and compliance.
- Support and oversee CAPA, change control, validation, and other Quality System activities.
- Partner cross-functionally with Manufacturing, Process Development, Validation, Quality Control, Warehouse, Engineering, Facilities, Environmental, and Contractors to ensure compliance with established procedures.
- Provide Quality support for New Product Introduction (NPI) and complex projects.
- Support internal and external audits and regulatory inspections, serving as a Quality representative when required.
- Support commissioning and qualification activities and GxP application validation, including risk assessments and IQ/OQ/PQ documentation.
- Analyze quality data and trends, evaluate compliance issues, and provide recommendations to address quality and operational risks.
- Participate in and lead continuous improvement initiatives and quality projects.
- Communicate quality, compliance, supply, and safety risks to appropriate levels of management.
- Work independently while effectively leading, influencing, and collaborating with cross-functional teams.
BASIC QUALIFICATIONS
- Bachelor's degree in Science or Engineering
- Experience in Quality Assurance within a pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing environment.
- Strong working knowledge of cGMP, Quality Systems, deviations, CAPA, change control, and validation.
- Experience with batch record review and manufacturing documentation.
- Experience supporting NPI, audits/inspections, commissioning, qualification, or GxP validation.
- Knowledge of computer systems validation / computer systems quality assurance is highly desirable.
- Strong analytical, problem-solving, organizational, and project management skills.
- Ability to lead cross-functional teams and effectively influence and negotiate with stakeholders.
- Strong English and Spanish written and verbal communication skills.
- Proficiency with word processing, presentation, database, and spreadsheet applications.
- Ability to evaluate compliance issues and interpret quality data/trends.
- Ability to work independently and interact effectively with employees and leadership at all organizational levels.
- Non-Standard Shift
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
INTRODUCTION
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic individual to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities
- Perform on-the-floor Plant Quality Assurance (PQA) review and approval of cGMP manufacturing processes, procedures, testing methods, documents, and production records.
- Review and approve batch records, MES/EBR, SAP, EDMQ, DQMS, and TrackWise documentation, including deviations, CAPAs, and validations.
- Ensure deviations and quality events are properly triaged, investigated, documented, and resolved in accordance with procedures and cGMP requirements.
- Review and assess changes for potential impact to product quality and compliance.
- Support and oversee CAPA, change control, validation, and other Quality System activities.
- Partner cross-functionally with Manufacturing, Process Development, Validation, Quality Control, Warehouse, Engineering, Facilities, Environmental, and Contractors to ensure compliance with established procedures.
- Provide Quality support for New Product Introduction (NPI) and complex projects.
- Support internal and external audits and regulatory inspections, serving as a Quality representative when required.
- Support commissioning and qualification activities and GxP application validation, including risk assessments and IQ/OQ/PQ documentation.
- Analyze quality data and trends, evaluate compliance issues, and provide recommendations to address quality and operational risks.
- Participate in and lead continuous improvement initiatives and quality projects.
- Communicate quality, compliance, supply, and safety risks to appropriate levels of management.
- Work independently while effectively leading, influencing, and collaborating with cross-functional teams.
BASIC QUALIFICATIONS
- Bachelor's degree in Science or Engineering
- Experience in Quality Assurance within a pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing environment.
- Strong working knowledge of cGMP, Quality Systems, deviations, CAPA, change control, and validation.
- Experience with batch record review and manufacturing documentation.
- Experience supporting NPI, audits/inspections, commissioning, qualification, or GxP validation.
- Knowledge of computer systems validation / computer systems quality assurance is highly desirable.
- Strong analytical, problem-solving, organizational, and project management skills.
- Ability to lead cross-functional teams and effectively influence and negotiate with stakeholders.
- Strong English and Spanish written and verbal communication skills.
- Proficiency with word processing, presentation, database, and spreadsheet applications.
- Ability to evaluate compliance issues and interpret quality data/trends.
- Ability to work independently and interact effectively with employees and leadership at all organizational levels.
- Non-Standard Shift
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
See all 1,088+ H-1B Visa QA Engineer Jobs
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a QA Engineer
Map your degree to the SOC code
USCIS evaluates whether your degree field directly relates to QA Engineering. Pull the O*NET profile for Software Quality Assurance Analysts to confirm the standard education requirements before an employer files your LCA.
Filter employers by LCA filing history
Use Migrate Mate to search QA Engineer roles at employers with verified H-1B Labor Condition Application filings. This surfaces companies that have already cleared DOL certification for this specific occupation, not just companies open to sponsorship in theory.
Check prevailing wage before negotiating salary
Your employer must pay at least the DOL prevailing wage for your location and job level. Run your title and metro area through the OFLC Wage Search before your offer conversation so you know the wage floor USCIS will scrutinize.
Clarify specialty occupation in your offer letter
QA Engineer petitions face RFEs when the job description is too broad. Ask your employer to specify that the role requires a bachelor's degree in a directly related technical field, not just any degree, in both the offer letter and I-129 support documentation.
Account for cap-gap if transitioning from F-1 OPT
If your OPT expires between April 1 and October 1, cap-gap rules extend your work authorization until your H-1B start date. Confirm your employer's HR team knows your status continues automatically so your QA role isn't paused while USCIS processes the petition.
Request premium processing for time-sensitive projects
USCIS offers premium processing for I-129 petitions, guaranteeing a decision within a set business-day window. If your employer is onboarding you for a sprint cycle or product launch, premium processing eliminates the uncertainty of standard adjudication timelines.
H-1B Visa QA Engineer: Frequently Asked Questions
Does a QA Engineer role qualify as a specialty occupation for H-1B purposes?
Yes, provided the position requires a bachelor's degree or higher in computer science, software engineering, information systems, or a closely related technical field. Roles where any degree is acceptable, regardless of field, are vulnerable to USCIS specialty occupation challenges. Your employer should document in the I-129 petition that the specific degree field is a standard industry requirement for the role.
How do I find employers who have already sponsored H-1B visas for QA Engineers?
Migrate Mate filters QA Engineer job listings by employer LCA filing history, showing you companies that have already filed Labor Condition Applications with DOL for this occupation. This is more reliable than asking recruiters, since LCA data is publicly disclosed and reflects actual filing activity rather than stated sponsorship policies.
Can a QA Engineer on OPT work for a company while their H-1B petition is pending?
Yes, if your employer files your H-1B petition before your OPT expires and USCIS selects you in the cap lottery, cap-gap automatically extends your F-1 work authorization until October 1. You can continue in your QA role during this period without interruption, provided your employer filed a timely petition and your OPT was still valid at the time of filing.
What happens to my H-1B status if I switch from a QA Engineer role to a software developer role at the same company?
A material change in job duties, title, or SOC code requires your employer to file an amended H-1B petition with USCIS before you begin the new role. A QA Engineer and a software developer occupy different Standard Occupational Classification codes, so the amendment is required even if your salary and location stay the same. Working in the new role before the amended petition is filed puts your status at risk.
Does my employer need to be E-Verify enrolled to sponsor my H-1B as a QA Engineer?
E-Verify enrollment isn't required for standard H-1B sponsorship. It becomes mandatory if you're on a STEM OPT extension transitioning to H-1B and your employer wants to remain a qualifying STEM OPT employer. USCIS's H-1B rules don't condition cap-subject petition filing on E-Verify participation, but some federal contractors are required to enroll regardless of visa type.