OPT Quality Management Systems Jobs
Quality Management Systems jobs on OPT are available across manufacturing, healthcare, aerospace, and tech, industries where F-1 students with engineering or science degrees find strong demand. Most roles qualify as STEM OPT extensions, giving you up to 36 months of work authorization to build compliance and QMS expertise in the U.S.
See All OPT Quality Management Systems JobsOverview
Showing 5 of 100+ Quality Management Systems jobs
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
See all 100+ Quality Management Systems Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Quality Management Systems roles.
Get Access To All JobsDescription:
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.
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.
See all 100+ OPT Quality Management Systems Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Quality Management Systems Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship in Quality Management Systems
Confirm your role qualifies for STEM OPT
Quality Management Systems roles typically fall under engineering or quality science SOC codes eligible for STEM OPT extension. Verify your degree field and job duties align before applying, since mismatches can complicate your extension filing with your DSO.
Target industries with high QMS hiring volume
Manufacturing, medical devices, aerospace, and pharmaceuticals rely heavily on ISO 9001 and FDA compliance frameworks. These sectors hire QMS professionals consistently and are more familiar with OPT work authorization, making them lower-friction targets for F-1 students.
Lead with certifications to offset visa hesitation
ISO 9001 Lead Auditor, Six Sigma Green Belt, or ASQ Certified Quality Engineer credentials signal readiness without training investment. Employers who see relevant certifications on a resume are more likely to engage before asking about work authorization status.
Clarify OPT paperwork requirements early
Many QMS hiring managers at mid-size manufacturers are unfamiliar with OPT. Prepare a one-page summary explaining your EAD card, authorized dates, and the E-Verify process. Removing ambiguity early prevents offers from stalling at the HR stage.
Frame your international background as an asset
QMS roles at companies with global supply chains value candidates who understand international quality standards. If your home country uses ISO or equivalent frameworks, connect that experience directly to the employer's compliance needs during interviews.
Apply early relative to your OPT start date
QMS hiring cycles at regulated industries like pharma and aerospace can take 60 to 90 days. Submit applications at least three months before your OPT begin date so offer timing, onboarding, and your authorized work start date can align cleanly.
Quality Management Systems OPT: Frequently Asked Questions
Do Quality Management Systems jobs qualify for the STEM OPT extension?
Most QMS roles qualify for the 24-month STEM OPT extension if your degree is in a STEM field such as engineering, industrial technology, or applied sciences. The job duties must align with your degree, and your employer must be E-Verify enrolled. Confirm the SOC code with your DSO before filing the extension to avoid complications.
How do I find QMS employers who are comfortable hiring OPT students?
Migrate Mate filters job listings specifically for OPT-friendly employers, so you can focus on companies already open to F-1 work authorization rather than sorting through postings that exclude visa holders. Large regulated industries like automotive, aerospace, and medical devices tend to have dedicated HR teams familiar with EAD-based hiring.
What should I say when an employer asks about my OPT status during a QMS interview?
Be direct: explain that you hold an EAD authorizing full-time employment, that no employer sponsorship is required during OPT, and that your authorization extends through a specific date. If you qualify for STEM OPT, mention that too, since it signals 36 months of employment without an H-1B visa petition. Bring a copy of your EAD to in-person interviews.
Can I work as a QMS consultant or contractor on OPT?
Yes, but with restrictions. OPT allows contract or consulting work as long as you receive direct compensation and work at least 20 hours per week. You cannot work for a staffing agency that places you as a third-party employee without a clear employment relationship. Self-employment in a consulting capacity is permitted if you own a business and it is your direct employer.
What happens to my OPT if my QMS employer conducts layoffs?
If your QMS role ends before your OPT expires, you have a 60-day unemployment grace period to find a new position. During this window you cannot work, but you can actively interview and accept offers. If you secure a new QMS role within 60 days, your OPT continues uninterrupted. Exceeding the unemployment limit triggers a status violation, so track your days carefully.