H-1B1 Chile Visa Quality Manager Jobs
Quality 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, and the 1,400-visa annual cap rarely fills. Employers file a Labor Condition Application with DOL, and you apply directly at the consulate with your quality credentials and job offer in hand.
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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 96+ H-1B1 Chile Visa Quality Manager Jobs
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Get Access To All JobsTips for Finding Visa Sponsorship as a Quality Manager
Translate your ISO credentials into U.S. equivalents
Chilean ISO 9001 lead auditor certifications and ANAB-accredited training carry weight with U.S. hiring managers, but you'll need to frame them against ASQ designations like CQM or CQE so recruiters and LCA reviewers recognize the equivalency.
Target manufacturers with active DOL LCA filings
Use the OFLC Wage Search to filter LCA disclosures by SOC code 11-3051 and identify which manufacturing or contract employers have a history of sponsoring Quality Managers specifically, not just engineers or operations roles.
Verify your job offer matches the specialty occupation definition
Your offer letter must describe duties that require at least a bachelor's degree in quality engineering, industrial engineering, or a directly related field. Generic titles like 'Quality Lead' without degree-specific requirements can complicate consular review.
Search H-1B1 Chile employer history on Migrate Mate
Migrate Mate surfaces DOL Labor Condition Application data filtered for H-1B1 Chile-eligible roles, so you can see which Quality Manager openings come from employers who have filed for Chilean nationals before and are prepared to sponsor.
Negotiate LCA filing before resigning your current role
The H-1B1 visa requires a certified LCA before your consular appointment. Confirm your U.S. employer has submitted and received DOL certification, typically within seven business days, before giving notice to your employer in Chile.
Prepare for nonimmigrant intent scrutiny at the consulate
Unlike H-1B visa, H-1B1 Chile does not allow dual intent, so consular officers will probe your ties to Chile. Bring documentation of property, family connections, or professional registrations that demonstrate your intent to return after each authorized period.
Frequently Asked Questions
Does a Quality Manager role qualify as a specialty occupation for the H-1B1 Chile visa?
Yes, Quality Manager qualifies when the position requires a bachelor's degree or higher in quality engineering, industrial engineering, manufacturing engineering, or a closely related field. The O*NET profile for General and Operations Managers and Quality Control Systems Managers both list a bachelor's degree as standard entry-level education. Your offer letter must reflect those degree requirements explicitly.
How does the H-1B1 Chile visa differ from H-1B for Quality Manager roles?
H-1B1 Chile has no lottery and no USCIS petition requirement, so your employer skips the I-129 filing entirely and you apply at the consulate once the DOL certifies the LCA. The tradeoff is that H-1B1 does not allow dual intent, meaning you cannot simultaneously pursue a green card while on H-1B1 status the way some H-1B holders do.
How do I find Quality Manager jobs where the employer is prepared to sponsor H-1B1 Chile?
Migrate Mate filters job listings using DOL Labor Condition Application data, showing you Quality Manager roles at employers with verified H-1B1 Chile filing history. This saves time compared to cold-applying at companies that may not understand the visa process or confuse H-1B1 Chile with a standard H-1B petition.
What wage level does my Quality Manager offer need to meet for the LCA?
Your employer must certify on the LCA that your offered wage meets or exceeds the prevailing wage for Quality Control Systems Managers under SOC code 11-3051 in the geographic area of employment. You can verify the applicable prevailing wage using the OFLC Wage Search before your offer is finalized to catch any gap early.
Can I switch employers after entering the U.S. on an H-1B1 Chile visa as a Quality Manager?
Yes, but H-1B1 visa does not carry the portability protections available under H-1B. Your new employer must file and receive a certified LCA before you begin work, and you will likely need to return to the consulate for a new visa stamp rather than relying on any in-country transfer process.