H-1B1 Chile Visa QA Engineer Jobs
QA Engineer jobs with H-1B1 Chile visa sponsorship are open to Chilean nationals under the U.S.-Chile Free Trade Agreement. The H-1B visa1 has no lottery, a 1,400-visa annual cap that rarely fills, and processes directly at the consulate, making it a faster and more predictable path than the H-1B for software quality professionals.
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Under the supervision of the QA Manager of the Human Gene and Cell Therapy Facility (HGCTF), the HGCTF QA Officer is responsible for the day-to-day Good Manufacturing Practices (GMP) quality assurance compliance activities including document control testing of these products to ensure that the products meet the required quality.
The QA Officer must have knowledge of GMP quality assurance compliance activities including management of OOS, deviations, CAPA and change control documents, releasing reagents per established procedures, establishing quality standards relating to QA/QC to ensure that the organization meets applicable State, Federal and accrediting agency regulatory requirements, actively monitoring changes in the Federal regulations and other accrediting agencies’ standards to ensure continued compliance with current regulations and standards, and maintaining core competencies as a Quality Assurance Inspector. Responsible for writing, reviewing and approval of Master Production (batch) Records, Standard Operating Procedures (SOPs), worksheets, forms, Specifications, Validation Protocols and reports, and Production Record Control systems to ensure compliance. The QA Officer is responsible for evaluating and interpreting regulations and standards to determine applicability and for effectively communicating such applicability. They will also perform routine audits and inspections to ensure compliance and provide written reports of such, ensuring appropriate responses and follow-up. They must ensure issues of critical non-compliance are handled in an appropriate and timely manner.
Annual Salary Range: $82,425.00 - $171,780.00
Qualifications
* Bachelor’s or Master’s degree in Biology, Chemistry, or related field with at least one year of GMP Quality Assurance experience; OR a PhD or PharmD with demonstrated knowledge of GMP Quality Assurance principles.
* Previous experience directly involved with federal regulations regarding GLP and GMP.
* Strong interpersonal communication skills to effectively and diplomatically interact with physicians, staff, administration & sponsors.
* Demonstrated skill in gathering pertinent data, preparing narrative reports, statistical reports, charts, graphs, and tables.
* Demonstrated ability to carry out analytical tasks, to identify and define issues and alternatives, to resolve problems, and to draw logical conclusions.
* Demonstrated skill in reviewing data and material compiled by others for completeness and accuracy to ensure that incorrect/incomplete data is corrected.
* Ability to deal with and maintain confidential and sensitive information with discretion. Ability to determine what information is confidential and to protect the confidentiality of that information.
* On occasion, ability to work flexible hours. Ability to attend off-site staff meetings, conferences and investigator meetings.
* Excellent English-writing skills to compose, proofread correspondence and written reports for conciseness, clarity, appropriate grammar, correct spelling, and proper punctuation.
* Ability to write concise and accurate administrative reports, policies, procedures, and correspondence.
* Working knowledge of some medical and scientific terminology for protocol abstracting and conversation with research personnel.
* Demonstrated skills with personal computers, spreadsheets, databases and word processing applications for the maintenance of administrative records, analysis of data, and the preparation of reports. Demonstrated skill in utilizing programs such as Word, Excel, and other database software. Ability to learn other systems/software as required.
* Demonstrated knowledge of FDA Good Laboratory Practice, Good Tissue Practice and Good Manufacturing Practice guidelines.
* Demonstrated ability to develop and monitor quality improvement plans and SOPs.
Description
Under the supervision of the QA Manager of the Human Gene and Cell Therapy Facility (HGCTF), the HGCTF QA Officer is responsible for the day-to-day Good Manufacturing Practices (GMP) quality assurance compliance activities including document control testing of these products to ensure that the products meet the required quality.
The QA Officer must have knowledge of GMP quality assurance compliance activities including management of OOS, deviations, CAPA and change control documents, releasing reagents per established procedures, establishing quality standards relating to QA/QC to ensure that the organization meets applicable State, Federal and accrediting agency regulatory requirements, actively monitoring changes in the Federal regulations and other accrediting agencies’ standards to ensure continued compliance with current regulations and standards, and maintaining core competencies as a Quality Assurance Inspector. Responsible for writing, reviewing and approval of Master Production (batch) Records, Standard Operating Procedures (SOPs), worksheets, forms, Specifications, Validation Protocols and reports, and Production Record Control systems to ensure compliance. The QA Officer is responsible for evaluating and interpreting regulations and standards to determine applicability and for effectively communicating such applicability. They will also perform routine audits and inspections to ensure compliance and provide written reports of such, ensuring appropriate responses and follow-up. They must ensure issues of critical non-compliance are handled in an appropriate and timely manner.
Annual Salary Range: $82,425.00 - $171,780.00
Qualifications
* Bachelor’s or Master’s degree in Biology, Chemistry, or related field with at least one year of GMP Quality Assurance experience; OR a PhD or PharmD with demonstrated knowledge of GMP Quality Assurance principles.
* Previous experience directly involved with federal regulations regarding GLP and GMP.
* Strong interpersonal communication skills to effectively and diplomatically interact with physicians, staff, administration & sponsors.
* Demonstrated skill in gathering pertinent data, preparing narrative reports, statistical reports, charts, graphs, and tables.
* Demonstrated ability to carry out analytical tasks, to identify and define issues and alternatives, to resolve problems, and to draw logical conclusions.
* Demonstrated skill in reviewing data and material compiled by others for completeness and accuracy to ensure that incorrect/incomplete data is corrected.
* Ability to deal with and maintain confidential and sensitive information with discretion. Ability to determine what information is confidential and to protect the confidentiality of that information.
* On occasion, ability to work flexible hours. Ability to attend off-site staff meetings, conferences and investigator meetings.
* Excellent English-writing skills to compose, proofread correspondence and written reports for conciseness, clarity, appropriate grammar, correct spelling, and proper punctuation.
* Ability to write concise and accurate administrative reports, policies, procedures, and correspondence.
* Working knowledge of some medical and scientific terminology for protocol abstracting and conversation with research personnel.
* Demonstrated skills with personal computers, spreadsheets, databases and word processing applications for the maintenance of administrative records, analysis of data, and the preparation of reports. Demonstrated skill in utilizing programs such as Word, Excel, and other database software. Ability to learn other systems/software as required.
* Demonstrated knowledge of FDA Good Laboratory Practice, Good Tissue Practice and Good Manufacturing Practice guidelines.
* Demonstrated ability to develop and monitor quality improvement plans and SOPs.
See all H-1B1 Chile Visa QA Engineer Jobs
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Get Access To All JobsTips for Finding Visa Sponsorship as a QA Engineer
Verify your degree maps to QA
Your Chilean engineering or computer science degree must align directly with the QA Engineer role. Use O*NET to confirm the occupation's educational requirements so you can show the consular officer a clear degree-to-job match.
Benchmark your salary against prevailing wage
Before any offer, look up the Level I–IV wage for your target metro area using the OFLC Wage Search. Your offered salary must meet or exceed the prevailing wage for the SOC code tied to QA Engineer roles, or the LCA won't certify.
Find H-1B1 Chile sponsors on Migrate Mate
Search Migrate Mate to identify employers whose DOL Labor Condition Application filings show active H-1B1 Chile sponsorship history for QA and software quality roles, so you're targeting companies that have already navigated this visa category.
Target employers with existing LCA infrastructure
Mid-size software and fintech companies often have in-house immigration counsel who already understand LCA filing requirements. Prioritize roles at employers where job postings explicitly reference visa sponsorship for specialty occupation positions.
Get your LCA certified before the consulate date
The employer must have a certified LCA from DOL before you attend your visa interview. Confirm this step is complete in writing, since H-1B1 Chile applications are consulate-processed and a missing LCA will stall your approval on the day.
Prepare for specialty occupation questions at the interview
Consular officers assess whether QA Engineer qualifies as a specialty occupation requiring at least a bachelor's degree in a directly related field. Bring your degree credential, translated transcripts, and the job description to demonstrate the degree-job connection clearly.
Frequently Asked Questions
Does a QA Engineer role qualify as a specialty occupation for the H-1B1 Chile visa?
Yes, QA Engineer qualifies when the position requires at least a bachelor's degree in computer science, software engineering, or a directly related field. The employer must document this requirement in the Labor Condition Application and supporting materials. Roles that accept any degree or substitute years of experience without a degree requirement may face scrutiny at the consulate.
How is the H-1B1 Chile visa different from the H-1B for QA engineers?
The H-1B1 Chile has no lottery and a 1,400-visa annual cap that has never been exhausted, so Chilean QA engineers apply directly at the consulate without waiting for a USCIS registration or selection. The trade-off is that H-1B1 Chile doesn't confer dual intent, so you'll need to maintain nonimmigrant intent throughout your stay, unlike the H-1B which permits green card pursuit.
How can I find QA Engineer jobs with H-1B1 Chile visa sponsorship?
Migrate Mate lets you filter job listings by employers with verified H-1B1 Chile Labor Condition Application filing history, so you're applying to companies that have already sponsored this visa category for software and QA roles. General job boards don't surface this filing data, which means you can't tell whether an employer will actually follow through on sponsorship.
What documents do Chilean QA engineers need for the H-1B1 Chile consulate interview?
You'll need your certified LCA from DOL, a support letter from the employer describing the QA Engineer role and its degree requirements, your Chilean passport valid for at least six months beyond the intended entry date, academic transcripts with certified translations if issued in Spanish, and your DS-160 confirmation. USCIS form I-129 is not required for H-1B1 Chile consulate applications.
Can a Chilean QA engineer renew the H-1B1 visa without leaving the U.S.?
The H-1B1 Chile is issued in one-year increments and requires renewal at a consulate outside the U.S. rather than through a USCIS status extension in most cases. Many Chilean QA engineers renew during a trip home or at a third-country consulate. Unlike H-1B, there's no change-of-status route that avoids a consulate visit for H-1B1 renewals.