Quality Management Systems Jobs in USA with Visa Sponsorship
Quality Management Systems roles qualify for H-1B visa and E-3 visa sponsorship when the position requires a bachelor's degree in engineering, industrial technology, or a related field. Employers in manufacturing, medical devices, aerospace, and pharmaceuticals regularly sponsor QMS professionals. For detailed occupation requirements, see the O*NET profile.
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Get Access To All JobsAt Editas Medicine, we are pioneering the possible. Our mission and commitment is to translate the power and potential of the CRISPR/Cas12a and CRISPR/Cas9 genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases.
Why Choose Editas?
At Editas Medicine, we’re a team of passionate problem solvers, harnessing the power and potential of CRISPR gene editing to transform the future of medicine. Driven by a shared purpose to serve people living with serious diseases, we succeed together through collaboration, mutual respect, and innovation. If you want to be part of a team where your voice is heard and respected, where you can operate at the forefront of gene editing, and push the boundaries of what’s possible in medicine, come join us and become an Editor!
Decoding The Role:
The primary focus of this role in the next 12 months is to advance our lead in vivo development candidate, EDIT-401, into the clinic by maintaining, enhancing, and supporting phase-appropriate quality systems and vendor management processes. This role is part of a collaborative QA team, offering opportunities to broaden expertise across multiple Quality disciplines. EDIT-401 is a potential best-in-class, one-time therapy designed to significantly reduce LDL cholesterol levels. The company is excited by the potential of this experimental treatment, which has demonstrated the ability to reduce mean LDL cholesterol levels by over 90 percent in non-human primates.
Characterizing Your Impact:
As the Senior Specialist, Quality Systems Management, you will:
- Serve as a subject matter expert for Quality Systems, supporting their effectiveness, compliance, and continuous improvement.
- Support the administration, maintenance, and optimization of the electronic document management system (Veeva QualityDocs), electronic quality management system (Veeva QMS), and learning management system (ComplianceWire).
- Execute and support risk-based supplier management activities, including vendor qualification, performance monitoring, and audit coordination.
- Author, review, and manage GMP documentation, including SOPs, work instructions, and training materials associated with Quality Systems.
- Partner cross-functionally to implement, maintain, improve, monitor, and report on quality and compliance processes.
- Support Quality Operations activities, including record reviews, disposition support, and Quality Event assessments.
- Assist with internal and external audits, inspections, and follow-up activities as needed.
- Identify opportunities for process enhancements and contribute to initiatives that strengthen Quality Systems and compliance performance.
Requirements The Ideal Transcript:
To thrive in this role, you'll need:
- Strong experience administering and/or supporting electronic document management systems, Quality Management Systems, and learning management systems.
- Experience supporting vendor qualification, vendor management, and supplier auditing activities.
- Demonstrated expertise working within cGMP-regulated environments and managing GMP documentation.
- Working knowledge of ICH Q10, FDA regulations, applicable international regulatory standards, and regulatory expectations for clinical-stage biotechnology products, including gene therapy.
- Ability to work independently while collaborating effectively within a cross-functional, team-oriented environment.
- Strong analytical, problem-solving, and critical-thinking skills.
- Excellent organizational and prioritization skills with the ability to manage multiple activities simultaneously.
- Experience supporting biologics, protein, RNA, cell therapy, gene therapy, viral vector, and/or related products.
- Bachelor's degree in a scientific discipline with 5-8 years of Quality Systems, Quality Assurance, or related experience within the biopharmaceutical industry.
Fundamentals That Set You Apart
- Experience supporting Quality Systems within early-phase clinical development organizations.
- Hands-on experience with Veeva Quality applications.
- Auditor training and/or experience supporting supplier or internal audits.
- Experience supporting Quality Operations activities.
- Demonstrated ability to drive process improvements and support inspection readiness initiatives.
Benefits
Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.
Salary Range:
103,000 - 119,000
Pay Transparency
Editas Medicine is committed to transparency and accuracy in our hiring practices. The anticipated salary range for each position is posted within the role. The final salary offer will be determined based on a comprehensive assessment of the candidate's qualifications, including education, training, and relevant experience. Additional factors such as external market conditions, the role's criticality, and internal equity will also be considered. Editas Medicine's compensation philosophy ensures fair and equitable pay practices.
Aspire to be an Editor? We invite you to apply and join us at the forefront of innovation and be a key contributor to realizing Editas Medicine's mission of developing transformative medicines for people living with serious diseases.
At Editas Medicine, we are pioneering the possible. Our mission and commitment is to translate the power and potential of the CRISPR/Cas12a and CRISPR/Cas9 genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases.
Why Choose Editas?
At Editas Medicine, we’re a team of passionate problem solvers, harnessing the power and potential of CRISPR gene editing to transform the future of medicine. Driven by a shared purpose to serve people living with serious diseases, we succeed together through collaboration, mutual respect, and innovation. If you want to be part of a team where your voice is heard and respected, where you can operate at the forefront of gene editing, and push the boundaries of what’s possible in medicine, come join us and become an Editor!
Decoding The Role:
The primary focus of this role in the next 12 months is to advance our lead in vivo development candidate, EDIT-401, into the clinic by maintaining, enhancing, and supporting phase-appropriate quality systems and vendor management processes. This role is part of a collaborative QA team, offering opportunities to broaden expertise across multiple Quality disciplines. EDIT-401 is a potential best-in-class, one-time therapy designed to significantly reduce LDL cholesterol levels. The company is excited by the potential of this experimental treatment, which has demonstrated the ability to reduce mean LDL cholesterol levels by over 90 percent in non-human primates.
Characterizing Your Impact:
As the Senior Specialist, Quality Systems Management, you will:
- Serve as a subject matter expert for Quality Systems, supporting their effectiveness, compliance, and continuous improvement.
- Support the administration, maintenance, and optimization of the electronic document management system (Veeva QualityDocs), electronic quality management system (Veeva QMS), and learning management system (ComplianceWire).
- Execute and support risk-based supplier management activities, including vendor qualification, performance monitoring, and audit coordination.
- Author, review, and manage GMP documentation, including SOPs, work instructions, and training materials associated with Quality Systems.
- Partner cross-functionally to implement, maintain, improve, monitor, and report on quality and compliance processes.
- Support Quality Operations activities, including record reviews, disposition support, and Quality Event assessments.
- Assist with internal and external audits, inspections, and follow-up activities as needed.
- Identify opportunities for process enhancements and contribute to initiatives that strengthen Quality Systems and compliance performance.
Requirements The Ideal Transcript:
To thrive in this role, you'll need:
- Strong experience administering and/or supporting electronic document management systems, Quality Management Systems, and learning management systems.
- Experience supporting vendor qualification, vendor management, and supplier auditing activities.
- Demonstrated expertise working within cGMP-regulated environments and managing GMP documentation.
- Working knowledge of ICH Q10, FDA regulations, applicable international regulatory standards, and regulatory expectations for clinical-stage biotechnology products, including gene therapy.
- Ability to work independently while collaborating effectively within a cross-functional, team-oriented environment.
- Strong analytical, problem-solving, and critical-thinking skills.
- Excellent organizational and prioritization skills with the ability to manage multiple activities simultaneously.
- Experience supporting biologics, protein, RNA, cell therapy, gene therapy, viral vector, and/or related products.
- Bachelor's degree in a scientific discipline with 5-8 years of Quality Systems, Quality Assurance, or related experience within the biopharmaceutical industry.
Fundamentals That Set You Apart
- Experience supporting Quality Systems within early-phase clinical development organizations.
- Hands-on experience with Veeva Quality applications.
- Auditor training and/or experience supporting supplier or internal audits.
- Experience supporting Quality Operations activities.
- Demonstrated ability to drive process improvements and support inspection readiness initiatives.
Benefits
Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.
Salary Range:
103,000 - 119,000
Pay Transparency
Editas Medicine is committed to transparency and accuracy in our hiring practices. The anticipated salary range for each position is posted within the role. The final salary offer will be determined based on a comprehensive assessment of the candidate's qualifications, including education, training, and relevant experience. Additional factors such as external market conditions, the role's criticality, and internal equity will also be considered. Editas Medicine's compensation philosophy ensures fair and equitable pay practices.
Aspire to be an Editor? We invite you to apply and join us at the forefront of innovation and be a key contributor to realizing Editas Medicine's mission of developing transformative medicines for people living with serious diseases.
See all 2,808+ 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 JobsTips for Finding Quality Management Systems Jobs
Confirm the degree requirement is explicit
H-1B sponsorship requires the role to qualify as a specialty occupation, meaning a specific bachelor's degree must be required, not just preferred. Ask the employer how they define the educational requirement before assuming the role qualifies.
Target industries with established QMS hiring
Medical device, pharmaceutical, aerospace, and automotive manufacturers have mature QMS functions and sponsor visas routinely. These sectors deal with FDA and ISO compliance, which creates sustained demand for qualified QMS professionals with foreign national backgrounds.
Highlight your ISO and regulatory credentials
Certifications like ISO 9001 Lead Auditor, ASQ Certified Quality Engineer, or FDA 21 CFR experience strengthen your petition. USCIS evaluates your qualifications against the job, and industry credentials reinforce that the role requires specialized expertise.
Understand the H-1B lottery timing
H-1B registration opens in March each year, with a roughly 25% selection rate. Cap-exempt employers like universities and nonprofits can file anytime. Plan your job search timeline around the April 1 fiscal year start to avoid a year-long wait.
Ask employers about their sponsorship history
Not every employer who lists sponsorship as possible has actually done it before. Ask directly whether they have sponsored H-1B workers in the past and whether they work with an immigration attorney. Prior experience significantly reduces delays and petition errors.
Australian nationals should evaluate the E-3 first
The E-3 visa is exclusive to Australian citizens and has no lottery. It processes faster than the H-1B and allows unlimited two-year renewals. QMS roles at U.S. employers qualify when the position meets specialty occupation standards under the same criteria.
Frequently Asked Questions
Does a Quality Management Systems role qualify as an H-1B specialty occupation?
It depends on how the employer defines the position. If the job description requires a bachelor's degree in engineering, industrial technology, quality management, or a closely related field, it meets the specialty occupation threshold. Roles where any bachelor's degree is acceptable regardless of field are harder to approve. QMS positions at regulated manufacturers, particularly in medical devices and pharma, have the strongest track record with USCIS because the degree-to-job relationship is well-established.
What degree do I need for H-1B sponsorship in a QMS role?
A bachelor's degree in industrial engineering, mechanical engineering, manufacturing engineering, or quality management is most commonly accepted. Some employers also accept degrees in chemistry or biology for QMS roles in life sciences. If your degree is from outside the U.S., a credential evaluation confirming equivalency to a four-year U.S. bachelor's degree is required. Australian three-year bachelor's degrees are generally accepted as equivalent for E-3 visa purposes.
Which industries are most likely to sponsor visas for QMS professionals?
Medical device companies, pharmaceutical manufacturers, aerospace contractors, and automotive suppliers are the most active sponsors. These industries operate under strict regulatory frameworks, including FDA Quality System Regulations and ISO 9001, which creates a genuine need for degree-holding QMS specialists. Federal contractors with defense work are also active sponsors. You can browse sponsoring employers hiring QMS professionals directly on Migrate Mate, which filters listings by visa sponsorship availability.
Can I switch QMS employers while on an H-1B visa?
Yes, under H-1B visa portability rules you can start working for a new employer as soon as they file an H-1B transfer petition, provided your current H-1B was approved and you've maintained lawful status. You don't need to wait for USCIS to approve the transfer. The new employer files a new Labor Condition Application and I-129 petition. Your total H-1B time counts against the six-year cap regardless of how many employers you've had.
Do QMS certifications like CQE or ISO Lead Auditor help with visa sponsorship?
They don't directly affect visa eligibility, but they strengthen the petition. USCIS reviewers assess whether the specific combination of your degree and the employer's job requirements justifies H-1B classification. Certifications like ASQ's Certified Quality Engineer or an ISO 9001 Lead Auditor credential reinforce that the role requires specialized, degree-level expertise rather than general business knowledge. Include them in your resume and ask your employer to reference them in the support letter.
What is the prevailing wage requirement for sponsored Quality Management Systems 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.