H-1B Visa Quality Specialist Jobs
Quality Specialist roles qualify for H-1B visa sponsorship when the position requires a bachelor's degree or higher in a directly related field such as engineering, chemistry, or quality management. Employers file an LCA with DOL before petitioning USCIS, certifying the role meets prevailing wage standards for your work location.
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Get Access To All JobsWork Schedule
First Shift (Days)
Environmental Conditions
Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.
Location/Division Specific Information
This is an on-site role based at our Detroit, Michigan campus, supporting our Biologicals and Chemicals Division. The Detroit Site maintains ISO 13485 Quality Management System (QMS) certification, manufacturing peptones and other fine chemicals used in bioproduction and culture media.
Discover Impactful Work:
The Quality Specialist II will have various responsibilities within Quality Assurance to support product release activities, ensuring on-time delivery to customers as well as initiatives for maintaining compliance to the QMS.
A day in the Life:
- Complete Quality record reviews including, but not limited to, batch history records, equipment and calibration documentation, QC records, and shipping records.
- Support timely delivery of products to customers through lot release (raw materials and manufactured product) and preparation of certificates of analysis.
- Respond to compliance-related customer inquiries in a timely manner, including but not limited to preparing certificates of origin and other regulatory documents, supplier questionnaires.
- Maintain Quality records according to Thermo Fisher Scientific policies and procedures.
- Maintain the site’s Quality Systems’ compliance to ISO 13485:2016 standards and regulatory requirements and policies as applicable.
- Support the execution of the site's training program.
- Support internal and external audits and ensure compliance with site and industry standards.
- Assist in completion of various QMS requirements, including but not limited to quality management reviews, change management including document change control, and customer notifications.
- Other projects will be assigned as various business needs arise.
Keys to Success:
Education
A Bachelor's Degree is required. A science major preferred.
Experience
- Minimum of 2 years' experience in a Quality Assurance function in an ISO 13485 environment. Familiarity with the life sciences industry is desired.
- Record review and/or auditing experience; ASQ CQA or ISO 13485 Lead Auditor or Internal Auditor certifications preferred but not required.
- Familiarity with enterprise software systems including ERPs, electronic document control systems, CAPA and training software packages.
Knowledge, Skills, Abilities
- Strong critical thinking skills, with a close attention to detail and history of good judgment.
- Proven ability to prioritize work according to urgency and impact, with good time management skills.
- Driven and resourceful, with minimal to moderate direction required.
- Proficiency in MS Office tools (e.g. Word, Excel, PowerPoint) and comfortable with learning and using new software programs.
- Strong technical writing skills.
- Proven ability to work in a team and matrixed environment.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255. Please include your contact information and specific details about your required accommodation to support you during the job application process.
This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Work Schedule
First Shift (Days)
Environmental Conditions
Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.
Location/Division Specific Information
This is an on-site role based at our Detroit, Michigan campus, supporting our Biologicals and Chemicals Division. The Detroit Site maintains ISO 13485 Quality Management System (QMS) certification, manufacturing peptones and other fine chemicals used in bioproduction and culture media.
Discover Impactful Work:
The Quality Specialist II will have various responsibilities within Quality Assurance to support product release activities, ensuring on-time delivery to customers as well as initiatives for maintaining compliance to the QMS.
A day in the Life:
- Complete Quality record reviews including, but not limited to, batch history records, equipment and calibration documentation, QC records, and shipping records.
- Support timely delivery of products to customers through lot release (raw materials and manufactured product) and preparation of certificates of analysis.
- Respond to compliance-related customer inquiries in a timely manner, including but not limited to preparing certificates of origin and other regulatory documents, supplier questionnaires.
- Maintain Quality records according to Thermo Fisher Scientific policies and procedures.
- Maintain the site’s Quality Systems’ compliance to ISO 13485:2016 standards and regulatory requirements and policies as applicable.
- Support the execution of the site's training program.
- Support internal and external audits and ensure compliance with site and industry standards.
- Assist in completion of various QMS requirements, including but not limited to quality management reviews, change management including document change control, and customer notifications.
- Other projects will be assigned as various business needs arise.
Keys to Success:
Education
A Bachelor's Degree is required. A science major preferred.
Experience
- Minimum of 2 years' experience in a Quality Assurance function in an ISO 13485 environment. Familiarity with the life sciences industry is desired.
- Record review and/or auditing experience; ASQ CQA or ISO 13485 Lead Auditor or Internal Auditor certifications preferred but not required.
- Familiarity with enterprise software systems including ERPs, electronic document control systems, CAPA and training software packages.
Knowledge, Skills, Abilities
- Strong critical thinking skills, with a close attention to detail and history of good judgment.
- Proven ability to prioritize work according to urgency and impact, with good time management skills.
- Driven and resourceful, with minimal to moderate direction required.
- Proficiency in MS Office tools (e.g. Word, Excel, PowerPoint) and comfortable with learning and using new software programs.
- Strong technical writing skills.
- Proven ability to work in a team and matrixed environment.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255. Please include your contact information and specific details about your required accommodation to support you during the job application process.
This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
See all 1,511+ H-1B Visa Quality Specialist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Quality Specialist Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Quality Specialist
Map your degree to the SOC code
USCIS scrutinizes whether your degree field directly supports a Quality Specialist role. Pull the O*NET profile for your target SOC code and confirm the listed education requirements match your transcript before applying.
Target manufacturers enrolled in E-Verify
Manufacturers and regulated industries like medical devices, aerospace, and pharmaceuticals file H-1B petitions most consistently for quality roles. E-Verify enrollment signals an employer already has infrastructure for work-authorization compliance.
Check prevailing wage before negotiating offers
Your employer's LCA must certify a wage at or above the DOL prevailing wage for your job title and location. Run the OFLC Wage Search for your specific SOC code before any offer conversation so you know the floor.
Use Migrate Mate to filter verified sponsors
Search Quality Specialist roles on Migrate Mate to see which employers have active H-1B LCA filing history for this occupation, so you're targeting companies with a documented record of sponsoring this role type.
Request premium processing before your OPT expires
Standard H-1B processing can run several months. If you're on OPT with a cap-gap window, ask your employer to file Form I-907 for premium processing so USCIS adjudicates within 15 business days and your start date isn't delayed.
Document quality certifications in your petition
ASQ certifications, ISO 9001 auditor credentials, and Six Sigma belts strengthen the specialty occupation argument in your I-129 petition. Compile official certification letters alongside your transcript to support the employer's filing.
H-1B Visa Quality Specialist: Frequently Asked Questions
Does a Quality Specialist role qualify as a specialty occupation for H-1B purposes?
It depends on how the employer defines the position. USCIS requires that the role normally demands at least a bachelor's degree in a specific field, not just any degree. A Quality Specialist tied to a regulated industry like medical devices, pharmaceuticals, or aerospace, with documented degree requirements in engineering or a science discipline, has a stronger specialty occupation argument than a generalist QA role.
Which industries sponsor H-1B visas for Quality Specialist roles most consistently?
Manufacturing sectors with federal regulatory requirements file H-1B petitions for quality roles most frequently. Medical device and pharmaceutical manufacturers must meet FDA quality system regulations, aerospace suppliers face FAA and AS9100 requirements, and automotive Tier 1 suppliers operate under IATF 16949. These compliance frameworks create ongoing demand for degreed quality professionals. You can browse employers with verified filing history on Migrate Mate.
How does the DOL prevailing wage requirement affect a Quality Specialist job offer?
Before your employer files the H-1B petition, they must submit an LCA to DOL certifying that your offered wage meets or exceeds the prevailing wage for your SOC code and work location. USCIS treats the LCA wage floor as a compliance requirement, not a suggestion. Offers that fall below the prevailing wage will cause the LCA to be rejected, blocking the entire petition.
Can my employer sponsor my H-1B if they've never done it before?
Yes. There's no requirement that an employer have prior H-1B sponsorship history. However, first-time sponsors must register for the annual H-1B lottery, file the LCA through DOL, and submit a complete I-129 petition to USCIS. The process is paperwork-intensive, and many first-time sponsors work with an immigration attorney to avoid filing errors that could delay or jeopardize the petition.
What happens to my H-1B status if I change Quality Specialist roles at a new employer?
You can transfer your H-1B to a new employer through portability under AC21, which allows you to start working for the new employer as soon as they file the transfer petition, without waiting for approval. The new employer must file a new LCA and I-129 covering the new role. If the new Quality Specialist position differs substantially in duties or location, USCIS may review whether it still qualifies under the original approval terms.