H-1B Visa Quality Systems Specialist Jobs
H-1B visa jobs for Quality Systems Specialist roles draw employers in regulated industries like pharmaceuticals, medical devices, and manufacturing, where degree-level expertise in quality management systems, regulatory compliance, and process validation meets the specialty occupation standard USCIS requires for sponsorship.
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About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
Purpose:
The Quality Systems Associate Specialist is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.
Responsibilities:
- Assist with proper integration and support of quality regulations: drug, biologics, device and/or combination products.
- Assist project teams in planning, preparation, review and approval of quality documentation.
- Complete and route change requests for process document creation, maintenance, and implementation.
- Create quality system documentation and specifications with guidance from technical teams following approved templates and guidelines.
- Assist with or co-lead audits of documentation, facilities and equipment.
- Assist in the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system.
- Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
- Participate in training and education programs for various aspects of quality assurance.
Qualifications
- Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
- 3+ years’ experience in quality assurance, quality oversight or relevant experience.
- Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
- Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products preferred.
- Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products preferred.
- Experience working in both team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
- Strong oral and written communication skills needed.
- Excellent interpersonal skills a plus.
- Runs small projects to deliver tactical results.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
Purpose:
The Quality Systems Associate Specialist is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.
Responsibilities:
- Assist with proper integration and support of quality regulations: drug, biologics, device and/or combination products.
- Assist project teams in planning, preparation, review and approval of quality documentation.
- Complete and route change requests for process document creation, maintenance, and implementation.
- Create quality system documentation and specifications with guidance from technical teams following approved templates and guidelines.
- Assist with or co-lead audits of documentation, facilities and equipment.
- Assist in the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system.
- Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
- Participate in training and education programs for various aspects of quality assurance.
Qualifications
- Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
- 3+ years’ experience in quality assurance, quality oversight or relevant experience.
- Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
- Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products preferred.
- Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products preferred.
- Experience working in both team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
- Strong oral and written communication skills needed.
- Excellent interpersonal skills a plus.
- Runs small projects to deliver tactical results.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
See all 32+ H-1B Visa Quality Systems Specialist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Quality Systems Specialist Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Quality Systems Specialist
Map your credentials to specialty occupation
Quality Systems Specialist roles qualify as specialty occupations when tied to a bachelor's degree in engineering, life sciences, or a directly related field. Pull your O*NET occupation profile and confirm your degree aligns before applying so your employer can build a defensible LCA.
Target regulated-industry employers for sponsorship
Pharma, biotech, medical device, and aerospace employers routinely sponsor H-1B visas for quality roles because FDA or FAA compliance demands degreed specialists. Use Migrate Mate to search employers with verified H-1B visa LCA filing history in these industries by role and location.
Verify prevailing wage before negotiating your offer
Your employer's LCA must certify a wage at or above the DOL prevailing wage for your SOC code and worksite. Run the OFLC Wage Search for your specific metro area before you negotiate, so you know the floor the employer is legally required to meet.
Confirm each worksite gets its own certified LCA
Quality roles in manufacturing or pharma sometimes require work across multiple plants or client sites. Each worksite location needs its own DOL-certified LCA before you can legally work there, so confirm your employer plans for all sites upfront during contract review.
Align your degree documentation before USCIS filing
If your quality credentials include a three-year international bachelor's degree or a mix of education and experience, get a credential evaluation completed before your employer files the I-129. USCIS scrutinizes degree relevance for quality roles, and gaps here trigger Requests for Evidence.
Understand the H-1B status window for career planning
H-1B status is granted for up to three years and can be extended to a six-year maximum. Quality professionals targeting regulated industries should factor that timeline into green card discussions with employers early, since PERM labor certification can take one to two years.
H-1B Visa Quality Systems Specialist: Frequently Asked Questions
Does a Quality Systems Specialist role qualify as an H-1B specialty occupation?
Yes, when the position genuinely requires at least a bachelor's degree in engineering, life sciences, chemistry, or a directly related field. Employers in regulated industries like pharmaceuticals, medical devices, and aerospace routinely structure these roles around degree-level duties covering regulatory frameworks such as ISO, FDA 21 CFR, or AS9100, which supports the specialty occupation determination USCIS requires.
Which industries sponsor H-1B visas most often for quality roles?
Pharmaceutical manufacturers, medical device companies, biotechnology firms, aerospace contractors, and semiconductor fabs sponsor H-1B visas for Quality Systems Specialists most consistently. These industries face FDA, FAA, or ISO regulatory requirements that make degreed quality professionals an operational necessity rather than a preference, which translates into active and recurring sponsorship activity. You can browse employers with verified filing history on Migrate Mate.
What happens to my H-1B status if my employer changes my worksite location?
Each new worksite requires its own DOL-certified Labor Condition Application before you begin working there. Your employer must file an amended or new LCA for any location not covered by the original certified LCA. If the move involves a materially different role or location, an amended I-129 petition with USCIS may also be required. Confirm the full plan with your employer before relocating.
How long does H-1B status last for a Quality Systems Specialist?
H-1B status is initially granted for up to three years and can be extended for a maximum of six years total under standard rules. Quality professionals seeking to remain longer typically need an employer-sponsored green card pathway, such as PERM labor certification followed by an EB-2 or EB-3 immigrant visa petition, which should be initiated well before the six-year cap approaches.
Can my employer use a staffing arrangement or consulting contract for H-1B sponsorship in this role?
Yes, but USCIS scrutinizes third-party placement arrangements closely for quality roles. The petitioning employer must demonstrate they have the right to control your work, including day-to-day supervision and direction. Consulting or staffing firm sponsors must provide end-client letters confirming the specialty occupation duties and employer-employee relationship. Contracts that lack these controls are common grounds for denial or Requests for Evidence.