Quality Auditor Jobs in USA with Visa Sponsorship
Quality auditor roles qualify for H-1B and E-3 sponsorship when the position requires a bachelor's degree in engineering, quality management, or a related technical field. Most sponsors are manufacturers, medical device firms, and aerospace contractors with established immigration programs. For detailed occupation requirements, see the O*NET profile.
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Get Access To All JobsExternal Supply Operations Quality (ESOQ Manager)
Role Description:
The Global External Quality Operations Mission is to be a proactive partner, driving a science and risk-based compliant quality culture that is flexible, innovative, and customer oriented, maximizing the contribution of Quality Operations to Our Path Forward initiatives.
External Supply Operations Quality (ESOQ) is committed to supporting Pfizer Global Supply (PGS) as an innovative and competitive advantage for Pfizer by assuring the quality of products manufactured and packaged by other companies (Contractors) for Pfizer.
ESOQ is responsible for the Quality & Regulatory management of approximately 300 contract manufacturers, packagers, and supply partners globally.
Responsibilities:
- The ESOQ Manager holds overall accountability for assigned CMOs, with primary responsibility for quality oversight (approximately 80%) and secondary responsibility for regulatory oversight (approximately 20%) across operational activities.
- The ESOQ Manager is accountable for providing quality assurance management of key contractors for Pfizer and for assuring that the products supplied to our patients are manufactured & tested in accordance with c-GMPs, the registration file and any additional country specific requirements.
- This is a highly independent position operating with minimal supervision, interacting with high levels of management both at contract manufacturers and within Pfizer.
- (S)he will operate as spokesperson for ESOQ and will focus on developing relationships, independently negotiating, developing and communicating Pfizer quality requirements with contract manufacturers.
- ESOQ Manager will have significant interactions with many internal business and manufacturing organizations (e.g. External Supply, Regulatory, Technical Support, Quality, PGS sites and R&D) and will lead virtual cross functional teams.
- Initiate, review and approve regulatory changes through Pfizer enterprise system (i.e. PDM) for changes initiated by or impacting ESOQ managed contractors.
- Provide support for the closure of the deficiency letters, CMC Commitments, Regulatory requests for Renewals, New Product Registrations and Post approval variations.
- Main point of contact for Global Chemistry, Manufacturing & Controls (CMC) or Local Regulatory Affairs in Pfizer Country Offices (Single market prods) for the regulatory activities involving the ESOQ contractors.
- As the Quality & Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) for ESOQ managed contractors and if needed, participate in Site Quality visits at the contractors.
- Support and Perform Lot Disposition for Biotech semi-finished and finished products (if applicable).
Qualifications
- Minimally BA/BS Science, Engineering, or related technical discipline with at least 7 years in a GXP setting and/or Regulatory Affairs role.
- At least 4 years of Product Quality Assurance experience in a GMP environment with Aseptic manufacturing experience.
- Advanced computer skills, MS Office and enterprise systems such as SAP, QTS, PDM, Documentum platforms.
- Command of English language required and multi-lingual is a benefit.
- Strong verbal and written communication including presentation skills.
- Shows strong negotiation skills and is diplomatic in communication with internal and external customers.
- Demonstrated ability to manage multiple projects and priorities.
- Demonstrated ability to prioritize work, to act and work independently and to escalate items as required to Team leader.
- Demonstrated excellent organization skills.
- Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor.
- Developing personal leadership to manage cross functional projects.
- Developing ability to resolve conflicts.
- Takes initiatives and is proactive, persistent.
- Has a broad GMP and technical know-how to handle emerging issues.
- Able to report remotely and deliver work independently.
- Up to 20% travel may be required.
Pay Rate Range
60 - 63 USD hourly
Additional Notes
Please note that contractors are engaged to provide services to Pfizer on a temporary basis in connection with a specific assignment. Contractors are hired and employed through Atrium, our third-party payrolling partner.
This job posting is for a temporary role as an employee of Atrium on assignment at Pfizer. The individual selected for this role will be offered the role as an employee of Atrium; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by Atrium upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements.
Benefits Information
Comprehensive Benefits Package available based on eligibility
- Medical, Dental, Vision
- Short-Term Disability (STD)
- Long-Term Disability (LTD)
- Supplemental and Voluntary Life Insurance
- 401(K)
- Commuter Benefit Program
External Supply Operations Quality (ESOQ Manager)
Role Description:
The Global External Quality Operations Mission is to be a proactive partner, driving a science and risk-based compliant quality culture that is flexible, innovative, and customer oriented, maximizing the contribution of Quality Operations to Our Path Forward initiatives.
External Supply Operations Quality (ESOQ) is committed to supporting Pfizer Global Supply (PGS) as an innovative and competitive advantage for Pfizer by assuring the quality of products manufactured and packaged by other companies (Contractors) for Pfizer.
ESOQ is responsible for the Quality & Regulatory management of approximately 300 contract manufacturers, packagers, and supply partners globally.
Responsibilities:
- The ESOQ Manager holds overall accountability for assigned CMOs, with primary responsibility for quality oversight (approximately 80%) and secondary responsibility for regulatory oversight (approximately 20%) across operational activities.
- The ESOQ Manager is accountable for providing quality assurance management of key contractors for Pfizer and for assuring that the products supplied to our patients are manufactured & tested in accordance with c-GMPs, the registration file and any additional country specific requirements.
- This is a highly independent position operating with minimal supervision, interacting with high levels of management both at contract manufacturers and within Pfizer.
- (S)he will operate as spokesperson for ESOQ and will focus on developing relationships, independently negotiating, developing and communicating Pfizer quality requirements with contract manufacturers.
- ESOQ Manager will have significant interactions with many internal business and manufacturing organizations (e.g. External Supply, Regulatory, Technical Support, Quality, PGS sites and R&D) and will lead virtual cross functional teams.
- Initiate, review and approve regulatory changes through Pfizer enterprise system (i.e. PDM) for changes initiated by or impacting ESOQ managed contractors.
- Provide support for the closure of the deficiency letters, CMC Commitments, Regulatory requests for Renewals, New Product Registrations and Post approval variations.
- Main point of contact for Global Chemistry, Manufacturing & Controls (CMC) or Local Regulatory Affairs in Pfizer Country Offices (Single market prods) for the regulatory activities involving the ESOQ contractors.
- As the Quality & Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) for ESOQ managed contractors and if needed, participate in Site Quality visits at the contractors.
- Support and Perform Lot Disposition for Biotech semi-finished and finished products (if applicable).
Qualifications
- Minimally BA/BS Science, Engineering, or related technical discipline with at least 7 years in a GXP setting and/or Regulatory Affairs role.
- At least 4 years of Product Quality Assurance experience in a GMP environment with Aseptic manufacturing experience.
- Advanced computer skills, MS Office and enterprise systems such as SAP, QTS, PDM, Documentum platforms.
- Command of English language required and multi-lingual is a benefit.
- Strong verbal and written communication including presentation skills.
- Shows strong negotiation skills and is diplomatic in communication with internal and external customers.
- Demonstrated ability to manage multiple projects and priorities.
- Demonstrated ability to prioritize work, to act and work independently and to escalate items as required to Team leader.
- Demonstrated excellent organization skills.
- Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor.
- Developing personal leadership to manage cross functional projects.
- Developing ability to resolve conflicts.
- Takes initiatives and is proactive, persistent.
- Has a broad GMP and technical know-how to handle emerging issues.
- Able to report remotely and deliver work independently.
- Up to 20% travel may be required.
Pay Rate Range
60 - 63 USD hourly
Additional Notes
Please note that contractors are engaged to provide services to Pfizer on a temporary basis in connection with a specific assignment. Contractors are hired and employed through Atrium, our third-party payrolling partner.
This job posting is for a temporary role as an employee of Atrium on assignment at Pfizer. The individual selected for this role will be offered the role as an employee of Atrium; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by Atrium upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements.
Benefits Information
Comprehensive Benefits Package available based on eligibility
- Medical, Dental, Vision
- Short-Term Disability (STD)
- Long-Term Disability (LTD)
- Supplemental and Voluntary Life Insurance
- 401(K)
- Commuter Benefit Program
How to Get Visa Sponsorship as a Quality Auditor
Target industries with high sponsorship rates
Medical device, aerospace, automotive, and pharmaceutical manufacturers file the most LCAs for quality auditor roles. These industries have formal compliance functions where degree requirements are standard, making H-1B specialty occupation approval more straightforward.
Confirm the role requires a specific degree
H-1B approval depends on the job qualifying as a specialty occupation. Quality auditor positions that specify engineering, industrial technology, or quality management degrees are far stronger candidates than roles listing any bachelor's degree as acceptable.
Get relevant certifications before you apply
ASQ certifications like CQA, CQE, or CQI strengthen your profile for sponsorship by demonstrating specialized knowledge employers value. They also support the specialty occupation argument USCIS evaluates during H-1B adjudication for auditor and inspector roles.
Ask about sponsorship before the final interview round
Many quality auditor roles at large manufacturers have sponsored before but don't advertise it. Raising visa requirements after an offer creates friction. Confirming sponsorship willingness during the second interview round avoids wasted time on both sides.
Australian applicants should prioritize E-3 pathways
The E-3 visa has no lottery and a 10,500 annual cap that has never been filled, making it significantly more predictable than H-1B for Australian quality professionals. Any employer who sponsors H-1B can sponsor E-3 with less cost and no randomness.
Use experience substitutions if your degree field doesn't match
If your degree is in an adjacent field, documented work experience auditing to ISO 9001, AS9100, or FDA quality standards can help bridge the specialty occupation argument. Three years of qualifying experience can substitute for one year of formal education.
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Get Access To All JobsFrequently Asked Questions
Can quality auditor roles qualify for H-1B sponsorship?
Yes, but only when the position requires a specific bachelor's degree rather than any degree in any field. Quality auditor roles tied to regulated industries like aerospace, pharmaceuticals, or medical devices are strongest because employers can document that the job routinely requires specialized technical knowledge at the degree level. Generic auditor titles at non-regulated companies face more scrutiny during adjudication.
What degree do I need for a sponsored quality auditor position?
Most sponsoring employers require a bachelor's degree in industrial engineering, mechanical engineering, quality management, or a closely related technical discipline. Some roles in highly regulated industries also accept degrees in chemistry, biology, or materials science when the auditing scope aligns with that field. A business or general management degree alone is unlikely to satisfy the specialty occupation requirement for H-1B purposes.
Which employers are most likely to sponsor quality auditor visas?
Large manufacturers in aerospace, medical devices, automotive, and pharmaceuticals file the most LCAs for quality auditor and quality engineer roles. Companies like Boeing, Medtronic, Raytheon, and major pharmaceutical contract manufacturers have established immigration programs and legal teams familiar with the process. You can browse quality auditor roles from verified sponsoring employers directly on Migrate Mate.
Does ASQ certification improve my chances of getting sponsored?
It helps but doesn't replace degree requirements for H-1B purposes. ASQ certifications like the Certified Quality Auditor or Certified Quality Engineer credential signal specialized expertise and make your profile more competitive with employers who have discretion over which candidates to pursue sponsorship for. They're particularly useful if your degree is in an adjacent field and you need to reinforce the specialty occupation argument.
Are there visa options for quality auditors outside the H-1B lottery?
Australian citizens qualify for the E-3 visa, which has no lottery and processes at U.S. consulates in Australia with typical wait times of two to six weeks. Canadian and Mexican citizens in quality roles may qualify for TN status under the NAFTA-derived USMCA agreement, though the engineer or scientist classification must fit the role precisely. Both paths are faster and more predictable than H-1B for eligible nationals.
What is the prevailing wage requirement for sponsored Quality Auditor jobs?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.
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