H-1B1 Chile Visa Quality Assurance Manager Jobs
Quality Assurance Manager jobs with H-1B1 Chile visa sponsorship are open to Chilean nationals under the U.S.-Chile Free Trade Agreement. No lottery, no USCIS petition filing, and the 1,400-visa annual cap rarely fills, making this one of the most direct paths for Chilean QA professionals into U.S. manufacturing, tech, and regulated industries.
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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 Quality Assurance Manager Jobs
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Get Access To All JobsTips for Finding Visa Sponsorship as a Quality Assurance Manager
Translate your QA credentials for U.S. employers
Chilean quality certifications like INAPI-recognized ISO auditor credentials don't always map cleanly to U.S. job postings. Get your credentials evaluated by a NACES-member service and frame them against ASQ-recognized equivalents before you apply.
Target industries with documented H-1B1 LCA filings
Search the OFLC Wage Search for Quality Assurance Manager LCA filings by industry. Medical device, aerospace, and semiconductor employers file consistently for this role and already understand specialty occupation documentation requirements.
Find H-1B1 Chile sponsors using Migrate Mate
Migrate Mate filters job listings by employers with verified H-1B1 Chile visa sponsorship history, so you're not guessing which companies will support your application. Use it to target QA Manager roles directly rather than cold-applying broadly.
Confirm specialty occupation status before negotiating
The H-1B1 visa requires your role to qualify as a specialty occupation under the U.S.-Chile FTA. Ask your prospective employer to confirm the position requires a bachelor's degree in a directly related field before you enter offer negotiations or the LCA is filed.
Check the prevailing wage tier your role falls under
DOL assigns QA Manager roles to wage levels based on supervision scope, complexity, and industry. Pull your occupation's O*NET classification and cross-reference it with the OFLC Wage Search to verify your offered salary meets the certified wage level before your employer submits the LCA.
Time your consulate appointment around LCA certification
Your employer's LCA must be certified by DOL before you can apply at the consulate. DOL typically certifies within seven business days, but build in buffer time so your DS-160 submission and appointment scheduling aren't delayed by a certification lag.
Frequently Asked Questions
Does a Quality Assurance Manager role qualify as a specialty occupation for the H-1B1 Chile visa?
Yes, provided the position requires a bachelor's degree or higher in a directly related field such as industrial engineering, quality management, or a physical science. Roles that accept any degree discipline or substitute years of experience for educational requirements can fail the specialty occupation test, so your employer's LCA documentation must tie the job duties explicitly to a qualifying degree field.
How does the H-1B1 Chile visa differ from H-1B for Quality Assurance Manager roles?
The H-1B1 Chile visa has no lottery and no USCIS petition requirement. You apply directly at the U.S. consulate in Chile after your employer obtains DOL's LCA certification, which is typically faster than the full H-1B visa petition process. The annual cap of 1,400 visas for Chilean nationals has historically gone unfilled, so availability is not a practical constraint the way H-1B cap exhaustion often is.
What documentation does your employer need to file before you can apply for the H-1B1?
Your employer files a Labor Condition Application with DOL and receives certification before you can apply at the consulate. The LCA certifies that the offered wage meets the prevailing wage for your occupation and work location, and that hiring you won't adversely affect working conditions for U.S. workers. USCIS is not involved in this process for H-1B1 visa applicants.
How do you find employers in the U.S. who will sponsor an H-1B1 Chile visa for a QA Manager?
Migrate Mate lets you search specifically for employers with verified H-1B1 Chile visa sponsorship history, filtering out companies that lack the familiarity or willingness to support this visa category. QA Manager roles in regulated industries like medical devices, aerospace, and food manufacturing tend to attract employers already experienced with specialty occupation filings and LCA documentation requirements.
Can you switch employers after entering the U.S. on an H-1B1 Chile visa?
Yes, but the H-1B1 doesn't carry H-1B portability rights. Your new employer must obtain a fresh LCA certification from DOL and you'll need to apply for a new H-1B1 visa stamp at the consulate before starting work for the new employer. There's no USCIS petition involved, but the consulate process means you can't simply port your authorization mid-employment the way H-1B holders sometimes can.