H-1B Visa Quality Assurance Engineer Jobs
Quality Assurance Engineer roles qualify as H-1B visa specialty occupations when the position requires a bachelor's degree or higher in computer science, engineering, or a related technical field. Employers file the LCA with DOL before sponsoring your H-1B, 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.
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Quality Assurance Engineer
Align your degree to the QA role
USCIS requires a direct connection between your degree field and the QA Engineer position. A degree in computer science, software engineering, or information systems strengthens your specialty occupation case more than a general business or unrelated technical degree.
Search LCA filings by SOC code
QA Engineers typically file under SOC code 15-1253. Use the OFLC Wage Search to pull certified LCA records for that code by employer and location, identifying which companies have an active pattern of sponsoring this specific role.
Target E-Verify enrolled employers early
STEM OPT extensions require E-Verify enrollment, so filtering for enrolled employers before your H-1B cap gap closes removes a critical compliance risk. Migrate Mate surfaces employer E-Verify status and LCA filing history so you can qualify candidates before applying.
Confirm prevailing wage tier before negotiating
DOL assigns your prevailing wage at Level I through IV based on experience and job duties. Your offer must meet the certified LCA wage, so check the OFLC Wage Search for the QA Engineer wage at your employer's worksite ZIP code before accepting any offer.
Ask about worksite location in the LCA
If your QA role involves client sites or remote work in a different metro area than your employer's office, the employer must file an amended LCA covering each worksite. Confirm this before your petition is filed to avoid an RFE on worksite documentation.
Document your QA methodology credentials
USCIS scrutinizes whether QA roles truly require a specialty degree. Certifications like ISTQB, CSTE, or formal test automation training paired with your degree transcript help establish that the position demands theoretical and practical knowledge beyond general IT skills.
H-1B Visa Quality Assurance Engineer: Frequently Asked Questions
Does a Quality Assurance Engineer role qualify as an H-1B specialty occupation?
Yes, provided the position genuinely requires a bachelor's degree or higher in a specific technical field such as computer science, software engineering, or information systems. Generic QA roles that accept any degree or substitute experience freely are more likely to receive an RFE from USCIS challenging the specialty occupation designation. The job description should specify the degree requirement explicitly.
Which employers sponsor H-1B visas for Quality Assurance Engineers?
Software companies, financial services firms, healthcare technology providers, and defense contractors are among the most consistent H-1B sponsors for QA Engineers. You can review certified LCA records by SOC code on the OFLC Wage Search to identify which employers have filed for this role. Migrate Mate also filters active job listings by employers with documented H-1B filing history for QA positions.
What happens to my H-1B status if my QA role shifts to fully remote?
Remote work changes require your employer to file an amended LCA covering each location where you'll work, with a posted notice at each worksite. If you move to a new metropolitan statistical area, the prevailing wage level may also change. USCIS expects the LCA to reflect your actual worksite, so notify your employer's immigration team before any permanent worksite change takes effect.
Can my employer transfer me between QA projects without filing an amended H-1B petition?
Project transfers within the same worksite location and at the same wage level generally don't require an amended petition, as long as the core duties remain substantially the same. A shift from manual testing to a lead automation engineering role with significantly different duties and a new title may constitute a material change requiring an amendment filed with USCIS before the new assignment starts.
How do I verify that a QA Engineer job posting is genuinely open to H-1B sponsorship?
Check whether the employer has a certified LCA on file for that role using the OFLC Wage Search, which shows recent DOL filings by employer name and job title. Postings that say 'sponsorship available' without any LCA history may reflect aspirational language rather than an established process. Targeting employers with a documented history of sponsoring QA Engineers reduces the risk of an offer that stalls at the petition stage.