Green Card Quality Engineering Specialist Jobs
Quality Engineering Specialist roles qualify for EB-2 or EB-3 green card sponsorship when employers can demonstrate no qualified U.S. workers are available through PERM labor certification. Your path to lawful permanent residency runs through I-140 approval and adjustment of status or consular processing, with per-country priority dates affecting your timeline.
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Get Access To All JobsCompany Overview:
Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology & oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities.
About The Role
Department: Quality Assurance
Reports to: VP, Quality Assurance
Location: Cambridge, MA
Position Summary
The Senior Quality Engineering Specialist provides hands-on operational support for Prime Medicine’s GxP software, equipment, calibration, preventive maintenance, and vendor oversight activities. Working with Quality, Laboratory Operations, IT/Informatics, system and equipment owners, and external vendors, the Specialist executes qualification activities, maintains accurate records, coordinates scheduled work, and helps keep systems and equipment compliant and inspection-ready. The role also conducts risk-based assessments of software vendors in accordance with current FDA guidance, as well as assessments of equipment and material suppliers and service providers, to ensure the quality and reliability of externally supplied inputs.
Key Responsibilities
Software Assurance and Vendor Assessments:
- Draft, execute, and review software assurance test scripts using approved requirements, specifications, risk assessments, and intended-use documentation.
- Support quality oversight of GxP computerized systems, including AI-enabled software tools, in accordance with company procedures and applicable regulatory expectations.
- Conduct and document risk-based assessments of software, equipment, material, and service providers.
- Collect and review vendor questionnaires, certifications, audit materials, quality agreements, and other supporting evidence.
- Work with IT/Informatics, system owners, Quality colleagues, and vendors to resolve documentation or performance gaps and complete assigned actions.
Equipment Qualification and Maintenance:
- Draft, execute, and review equipment qualification protocols, including IQ/OQ/PQ activities.
- Review executed protocols, reports, raw data, test results, certificates, and supporting records for completeness, accuracy, and consistency.
- Support the documentation and investigation of equipment qualification discrepancies.
- Maintain equipment, calibration, and preventive maintenance records in the computerized maintenance management system.
- Review and electronically maintain calibration certificates, maintenance records, and service reports, ensuring that documentation is complete and properly linked to the applicable equipment.
- Oversee scheduled calibration, maintenance, and service activities with equipment owners and external providers, escalating delays and compliance risks promptly.
Supplier Quality and Quality Systems Support:
- Conduct supplier audits and remote assessments under the direction of Supplier Quality leadership.
- Prepare assessment plans, document requests, questionnaires, reports, and follow-up actions.
- Track vendor corrective actions and other assigned quality actions through closure.
- Support change controls, deviations, CAPAs, and other quality records involving software, equipment, calibration, maintenance, or vendors.
- Maintain trackers, dashboards, and status reports for qualification activities, calibration and maintenance schedules, vendor assessments, and open actions.
- Identify recurring issues, documentation gaps, overdue activities, and opportunities for practical process improvement.
- Participate in audits, regulatory inspections, and inspection-readiness activities as needed.
Qualifications
- Bachelor’s degree in a scientific, engineering, technical, or quality-related field, or equivalent relevant experience.
- At least four years of experience in a regulated life-sciences environment, including experience in equipment qualification, software assurance/CSV, calibration or maintenance oversight, supplier quality, or a related quality function.
- Working knowledge of GxP documentation, data integrity, computerized systems, equipment qualification, calibration, and preventive maintenance requirements.
- Experience drafting, executing, or reviewing qualification protocols, test scripts, assessments, or other controlled quality records.
- Experience using a computerized maintenance management, calibration management, or equipment tracking system.
- Strong technical writing, organization, and cross-functional coordination skills.
- Ability to manage multiple operational priorities, maintain accurate records, and escalate risks or delays promptly.
Preferred Experience
- Experience in biotechnology, gene therapy, cell therapy, or another regulated life sciences environment.
- Familiarity with equipment lifecycle activities (URS, IQ/OQ/PQ, periodic review, calibration, maintenance) or software assurance/CSV practices.
- Experience supporting supplier qualification, vendor assessments, or laboratory instruments and CMMS records.
The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus) and an annual long-term incentive award (e.g., equity). Prime Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits—including medical, dental, vision, life insurance, a 401(k) match, and equity programs—along with generous paid time off, wellness days, and company-wide recharge breaks. Our commitment to employee well-being reflects our belief that when we care for our people, we strengthen our ability to put patients first and make meaningful impact together.
U.S. Pay Range $111,000—$123,000 USD
Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.
Company Overview:
Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology & oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities.
About The Role
Department: Quality Assurance
Reports to: VP, Quality Assurance
Location: Cambridge, MA
Position Summary
The Senior Quality Engineering Specialist provides hands-on operational support for Prime Medicine’s GxP software, equipment, calibration, preventive maintenance, and vendor oversight activities. Working with Quality, Laboratory Operations, IT/Informatics, system and equipment owners, and external vendors, the Specialist executes qualification activities, maintains accurate records, coordinates scheduled work, and helps keep systems and equipment compliant and inspection-ready. The role also conducts risk-based assessments of software vendors in accordance with current FDA guidance, as well as assessments of equipment and material suppliers and service providers, to ensure the quality and reliability of externally supplied inputs.
Key Responsibilities
Software Assurance and Vendor Assessments:
- Draft, execute, and review software assurance test scripts using approved requirements, specifications, risk assessments, and intended-use documentation.
- Support quality oversight of GxP computerized systems, including AI-enabled software tools, in accordance with company procedures and applicable regulatory expectations.
- Conduct and document risk-based assessments of software, equipment, material, and service providers.
- Collect and review vendor questionnaires, certifications, audit materials, quality agreements, and other supporting evidence.
- Work with IT/Informatics, system owners, Quality colleagues, and vendors to resolve documentation or performance gaps and complete assigned actions.
Equipment Qualification and Maintenance:
- Draft, execute, and review equipment qualification protocols, including IQ/OQ/PQ activities.
- Review executed protocols, reports, raw data, test results, certificates, and supporting records for completeness, accuracy, and consistency.
- Support the documentation and investigation of equipment qualification discrepancies.
- Maintain equipment, calibration, and preventive maintenance records in the computerized maintenance management system.
- Review and electronically maintain calibration certificates, maintenance records, and service reports, ensuring that documentation is complete and properly linked to the applicable equipment.
- Oversee scheduled calibration, maintenance, and service activities with equipment owners and external providers, escalating delays and compliance risks promptly.
Supplier Quality and Quality Systems Support:
- Conduct supplier audits and remote assessments under the direction of Supplier Quality leadership.
- Prepare assessment plans, document requests, questionnaires, reports, and follow-up actions.
- Track vendor corrective actions and other assigned quality actions through closure.
- Support change controls, deviations, CAPAs, and other quality records involving software, equipment, calibration, maintenance, or vendors.
- Maintain trackers, dashboards, and status reports for qualification activities, calibration and maintenance schedules, vendor assessments, and open actions.
- Identify recurring issues, documentation gaps, overdue activities, and opportunities for practical process improvement.
- Participate in audits, regulatory inspections, and inspection-readiness activities as needed.
Qualifications
- Bachelor’s degree in a scientific, engineering, technical, or quality-related field, or equivalent relevant experience.
- At least four years of experience in a regulated life-sciences environment, including experience in equipment qualification, software assurance/CSV, calibration or maintenance oversight, supplier quality, or a related quality function.
- Working knowledge of GxP documentation, data integrity, computerized systems, equipment qualification, calibration, and preventive maintenance requirements.
- Experience drafting, executing, or reviewing qualification protocols, test scripts, assessments, or other controlled quality records.
- Experience using a computerized maintenance management, calibration management, or equipment tracking system.
- Strong technical writing, organization, and cross-functional coordination skills.
- Ability to manage multiple operational priorities, maintain accurate records, and escalate risks or delays promptly.
Preferred Experience
- Experience in biotechnology, gene therapy, cell therapy, or another regulated life sciences environment.
- Familiarity with equipment lifecycle activities (URS, IQ/OQ/PQ, periodic review, calibration, maintenance) or software assurance/CSV practices.
- Experience supporting supplier qualification, vendor assessments, or laboratory instruments and CMMS records.
The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus) and an annual long-term incentive award (e.g., equity). Prime Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits—including medical, dental, vision, life insurance, a 401(k) match, and equity programs—along with generous paid time off, wellness days, and company-wide recharge breaks. Our commitment to employee well-being reflects our belief that when we care for our people, we strengthen our ability to put patients first and make meaningful impact together.
U.S. Pay Range $111,000—$123,000 USD
Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.
See all Green Card Quality Engineering Specialist Jobs
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Get Access To All JobsTips for Finding Green Card Sponsorship as a Quality Engineering Specialist
Document your specialized quality credentials early
Gather your ISO, ASQ, or Six Sigma certifications and performance validation records before engaging employers. PERM labor certification requires proving your qualifications meet the job's minimum requirements, and gaps in documentation slow adjudication significantly.
Target manufacturers with active PERM histories
Search Migrate Mate to find employers who have filed EB-2 or EB-3 green card sponsorship for Quality Engineering Specialist roles. Employers with prior PERM filings in this occupation already understand the recruitment test and prevailing wage requirements.
Verify your wage tier before PERM is filed
Use the OFLC Wage Search to look up the prevailing wage for your SOC code and work location before your employer submits a prevailing wage determination. If the offered salary falls below the DOL-certified level, your PERM will be denied.
Distinguish your O*NET profile from technician roles
Quality Engineering Specialists often share duties with quality technicians. Review O*NET to confirm your responsibilities align with the engineer-level occupation code, not the technician code. Misclassification in the PERM job description forces a refiling and restarts your priority date.
Ask about EB-2 versus EB-3 routing before you sign
If you hold a bachelor's degree plus five years of progressive quality engineering experience, you may qualify for EB-2 rather than EB-3. Confirm which category your employer's attorney intends to file under, since the category affects your priority date queue and backlog exposure.
Protect your priority date if you change employers
Once your original I-140 is approved, your priority date can carry over to a new employer's I-140 in the same or similar occupation. If your I-485 has been pending 180 days or more, AC21 portability also lets you change roles without losing your place in line.
Green Card Quality Engineering Specialist: Frequently Asked Questions
What green card categories cover Quality Engineering Specialist roles?
Most Quality Engineering Specialists qualify under EB-3 as professionals with a bachelor's degree, or under EB-2 if the role requires an advanced degree or a bachelor's degree plus five years of progressive experience. Your employer's attorney determines the appropriate category during PERM labor certification preparation. EB-2 may offer a shorter priority date queue depending on your country of birth.
How does green card sponsorship differ from H-1B for this role?
H-1B visa is a temporary nonimmigrant status requiring renewal every three years, with no guarantee of permanence. Green card sponsorship through EB-2 or EB-3 leads to lawful permanent residency. The PERM process requires your employer to conduct a formal recruitment test, obtain a prevailing wage determination from DOL, and file a labor certification before submitting the I-140 petition to USCIS. There is no lottery, but per-country priority date backlogs apply.
How long does the PERM process take for a Quality Engineering Specialist?
PERM labor certification involves a DOL prevailing wage determination, a mandatory recruitment period, and adjudication of the labor certification application. Processing times at DOL vary and USCIS then adjudicates the I-140 separately. Nationals from high-demand countries such as India or China may face significant priority date backlogs before an immigrant visa number becomes available, regardless of when PERM is certified.
Where can I find employers who sponsor green cards for Quality Engineering Specialist roles?
Migrate Mate lists U.S. employers with verified employment-based green card sponsorship history, searchable by role and location. Focusing on employers with prior EB-2 or EB-3 PERM filings in engineering or manufacturing occupations is more efficient than approaching general job boards, since those employers already have established immigration counsel and understand the PERM recruitment and wage requirements.
Can I change employers after my green card sponsorship is in progress?
Yes, under two distinct rules. If your original I-140 was approved, a new employer can file a new I-140 citing your earlier priority date, preserving your place in the backlog queue. Separately, if your I-485 adjustment of status application has been pending 180 days or more, AC21 portability allows you to move to a new job in the same or similar occupation without jeopardizing your pending case.