H-1B Visa Quality Management Systems Jobs
Quality Management Systems roles qualify as H-1B specialty occupations under the SOC 13-1111 category, requiring at least a bachelor's degree in quality management, industrial engineering, or a related field. Employers across manufacturing, pharmaceuticals, medical devices, and aerospace regularly sponsor H-1B petitions for QMS professionals with ISO 9001, AS9100, or IATF 16949 expertise.
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Description:
The Quality Compliance Specialist provides coordination and reporting that includes data collection/generation, data analysis and data review and interpretation. In addition, prepares summary findings to support change controls, planned deviations, new product launch compliance, as well as quality assurance trends related to various Quality Management processes.
Essential Functions:
- Reviews and approves (where applicable) respective data for the purpose of change, implementing, analyzing and reporting. The Associate collects / generates data for the purpose of analyzing and reporting. Additionally, supports preliminary investigations and prepares a summary of the findings to support NOIs, CAPAs, Complaints and other Quality related activities and projects. Regularly audits the tasks completed for reporting purposes and identification of any possible outstanding actions.
- Reviews all change controls, planned deviations, provide approvals (where applicable), issues tasks, monitor due dates for the associated tasks, necessary follow-up activities are performed until all requested tasks have been completed and events are closed. Holds the responsibility of coordinating in preparation, review and approval process of NPLs (New Product Launches) within the required time frame. Maintain, track all commitments made to the agency as part of submissions.
- Provides Senior Quality Management with timely data analysis and insights to support compliance to the systems and propose adequate corrective actions and applicable improvements.
- Will collaborate with personnel from other functional areas to collect information and coordinate discussions to facilitate the resolution of quality issues/concerns and distribute associated documentation as applicable.
- Act as a point of contact for assigned responsibilities towards external audits. Maintaining required concurrent documentation supporting regulatory audits.
- Regularly audits the Investigations and CAPA schedules for reporting purposes and identification of any possible outstanding actions.
- Prepare, review and present/submit all quality data with statistical approach. Act as a subject matter expert for electronic QMS. Notifies QM management of any activities or decisions that may impact the compliance of the sites that may lead to regulatory action. Prepares and/or ensures that extension documentation are in place for those which have been identified as unable to meet the scheduled due dates due to ongoing activities.
Additional Responsibilities:
- Assist with internal and regulatory audits as requested. Assist with analyzing, displaying and customizing data reports in formats such as scorecards and presentations on a bi-weekly, monthly and quarterly basis.
Education:
Bachelors Degree (BA/BS) Related QA Field Experience - Required
Experience:
3 years or more in Related QA Field Experience
Specialized Knowledge:
Organized, creative and the ability to communicate thoughts and ideas clearly. Able to present data and trends in a manner that is easily understood and is relatable.
Licenses:
Additional Requirement: This position requires successful completion of an OSHA-compliant Respirator Fit Test.
Compensation:
- Salary Range: $80,000 to $95,000 per year. Amneal ranges reflect the Company’s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills.
At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.
Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Quality Management Systems
Align your credentials to SOC codes
QMS roles are filed under multiple SOC codes depending on industry context. Check O*NET to confirm which code matches your specific duties, then ensure your resume and degree documentation reflect that classification before applying.
Target regulated-industry employers first
Pharmaceutical, medical device, and aerospace manufacturers have standing compliance obligations that make QMS hires non-discretionary. These employers file H-1B petitions more consistently than general manufacturing because regulatory audits require dedicated QMS staff year-round.
Verify prevailing wage before negotiating offers
Use the OFLC Wage Search to look up the prevailing wage for your SOC code and work location before an employer submits the LCA. Your offered salary must meet or exceed that figure, and knowing it prevents accepting an offer that USCIS will flag.
Check LCA filing history on Migrate Mate
Search QMS job titles by employer on Migrate Mate to see which companies have active LCA filings for your role type. This surfaces employers with a documented history of H-1B sponsorship in quality and compliance functions, not just those claiming they sponsor.
Clarify specialty occupation during the offer stage
QMS roles sometimes draw USCIS requests for evidence questioning whether the position requires a specific bachelor's degree. Ask your prospective employer to document in the job description that a degree in a directly related field is a minimum requirement, not a preference.
Account for cap timing if you're mid-OPT
If you're on OPT and receive an offer after April 1, your H-1B won't be active until October 1 at the earliest. Confirm your OPT expiration date and discuss a cap-gap bridging plan with the employer before signing, since continuous employment depends on unbroken authorization.
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Find Quality Management Systems JobsQuality Management Systems H-1B Visa: Frequently Asked Questions
Does a Quality Management Systems role qualify as an H-1B specialty occupation?
Yes, provided the employer's job description requires at least a bachelor's degree in a directly related field such as industrial engineering, quality management, or a relevant technical discipline. The key is specificity in the posting. Roles that accept any bachelor's degree regardless of field are more likely to receive a request for evidence from USCIS challenging specialty occupation status.
Which industries sponsor H-1B visas most often for QMS professionals?
Pharmaceuticals, medical devices, aerospace, and automotive manufacturing are the most active sponsors because their operations require ISO, FDA, or FAA compliance frameworks that mandate dedicated QMS staff. These industries face regulatory consequences for quality failures, so QMS hiring is driven by compliance necessity rather than discretionary budget. You can browse verified employers with LCA filing history for these roles on Migrate Mate.
How does the prevailing wage requirement affect QMS job offers?
Before your employer submits the LCA to DOL, they must certify your offered salary meets the prevailing wage for your SOC code and work location. You can look this up yourself using the OFLC Wage Search. If the offer falls below the applicable wage level, the LCA won't be certified, which blocks the H-1B petition from moving forward.
Can certifications like ISO 9001 Lead Auditor strengthen an H-1B petition for a QMS role?
Certifications alone don't satisfy the specialty occupation requirement, but they do support the employer's case that the role demands specialized expertise. When paired with a directly related bachelor's degree and a detailed job description, credentials like ISO 9001 Lead Auditor or ASQ Certified Quality Engineer help establish that the position goes beyond generalist management work.
What happens to my H-1B status if my employer loses a major contract and eliminates the QMS function?
If your employer terminates your position, you have a 60-day grace period to find a new sponsoring employer, transfer your H-1B through a portability filing, or depart the U.S. The new employer must file an H-1B transfer petition before the grace period ends. Your status doesn't transfer automatically, so starting the job search immediately is critical to maintaining lawful status.
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