H-1B Visa Quality Assurance Lead Jobs
Quality Assurance Lead roles qualify for H-1B visa sponsorship as specialty occupations requiring a bachelor's degree in engineering, computer science, or a related field. Employers file the LCA with DOL before your petition reaches USCIS, and the annual cap means timing your job search around the April filing window matters.
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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 Quality Assurance Lead Jobs
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Quality Assurance Lead
Map your degree to the SOC code
QA Lead roles typically file under SOC 15-1253 or 17-2112. Confirm your degree field aligns with the occupation USCIS will evaluate, since a mismatch between your diploma and the job's SOC code is a common RFE trigger.
Verify prevailing wage before negotiating salary
Run the OFLC Wage Search for your target metro and SOC code before you enter salary discussions. Your offer must meet the DOL prevailing wage for Level II or III, and underbidding yourself can complicate the LCA.
Target employers with active LCA filing history
Use Migrate Mate to filter QA Lead roles by employers who have filed LCAs for this occupation, so you're only applying where H-1B sponsorship is an established practice, not a first-time experiment.
Ask about cap-exempt employer status early
Universities, nonprofit research institutions, and certain government-affiliated entities are cap-exempt and can file your H-1B petition at any time of year. If you're open to those sectors, clarify employer status in your first recruiter conversation.
Prepare O*NET documentation for your petition
Pull the O*NET profile for your job code and confirm the listed tasks and education requirements mirror your offer letter's job duties. Employers use this in the specialty occupation letter to satisfy USCIS, so gaps between the two create RFE risk.
Plan your 60-day grace period job search timeline
If your current H-1B is ending, you have 60 days to secure a new employer who can file a transfer petition. QA Lead roles with active LCAs on file can move faster, since the prevailing wage step is already in progress.
H-1B Visa Quality Assurance Lead: Frequently Asked Questions
Does a Quality Assurance Lead role qualify as an H-1B specialty occupation?
Yes, provided the position genuinely requires a bachelor's degree or higher in a directly related field such as engineering, computer science, or a quality-focused discipline. Roles where any bachelor's degree satisfies the requirement, regardless of field, are more likely to receive an RFE. Your offer letter's job duties need to reflect the specialized nature USCIS expects.
Which employers sponsor H-1B visas for Quality Assurance Lead positions?
Manufacturers, software companies, medical device firms, and aerospace contractors are among the most consistent H-1B sponsors for QA Lead roles, since regulatory compliance requirements make specialized quality professionals essential. Browse Migrate Mate to find employers with verified LCA filing history for this occupation, so you can focus your applications where sponsorship is already established practice.
Can I transfer my H-1B to a new employer while staying in a QA Lead role?
Yes. An H-1B transfer, formally a portability filing, lets you start working for the new employer once they file the I-129 petition, without waiting for approval. The new employer must file a fresh LCA with DOL certifying the prevailing wage for your location and SOC code before submitting the petition to USCIS.
What documentation does an employer need to sponsor a QA Lead for H-1B?
The employer files a Labor Condition Application with DOL, then submits Form I-129 to USCIS with a support letter establishing that the QA Lead role is a specialty occupation. That letter typically references the O*NET profile for the occupation, the company's internal job requirements, and your academic credentials showing the degree-to-role alignment.
Does my QA Lead experience outside the U.S. count toward H-1B eligibility?
Work experience earned abroad can substitute for education under the three-for-one rule: three years of progressive, specialized experience in quality assurance or a related field can replace one year of a bachelor's degree. An independent credentials evaluation firm must document this equivalency, and your employer's attorney will include the evaluation in the I-129 petition package for USCIS review.