Green Card Quality Engineer Jobs
Quality Engineer roles at manufacturers, medical device companies, and aerospace contractors qualify for EB-2 and EB-3 green card sponsorship through PERM labor certification. Employers document recruitment efforts, file an I-140 petition, and sponsor you for permanent residency. Priority dates and country of birth determine your wait.
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Freenome is approaching FDA approval and commercial launch of SimpleScreen™, our cfDNA-based colorectal cancer detection test. As we cross that milestone, we need a dedicated owner for the postmarket quality infrastructure that commercial launch demands — someone who can build and run a complaint handling program that works across two distinct regulatory environments. This role also owns the CAPA program — ensuring that complaints and quality events drive real corrective action, not just documentation. You will serve as the escalation point and technical mentor for junior team members managing non-conformances and laboratory incidents, and you will be the Quality interface with our commercial partners to ensure customer and partner feedback is captured, evaluated, and acted on. This is a senior individual contributor role with significant cross-functional influence and a mentorship mandate. The role reports directly to the Senior Director, Quality Assurance and is an onsite role based in our Brisbane, California headquarters.
What You’ll Do
- Own the end-to-end complaint handling process — from intake and triage through technical investigation, root cause analysis, disposition, and closure — applying the distinct regulatory requirements applicable to CAP/CLIA laboratory quality events and IVD postmarket complaints under 21 CFR 820/QMSR and ISO 13485.
- Own the CAPA program: ensure that complaints, non-conformances, and laboratory quality events drive rigorous corrective action with documented root cause analysis, implementation, and effectiveness verification. Maintain CAPA records in the eQMS with traceability required for CAP/CLIA compliance.
- Serve as the escalation point and technical mentor for junior team members managing non-conformances and laboratory incidents — coaching investigation rigor, reviewing findings, and ensuring quality events at all levels feed appropriately into the CAPA program.
- Serve as the primary Quality liaison to commercial partners and customer-facing teams as it relates to complaints and CAPA: establish and maintain processes for capturing, routing, and evaluating partner- and customer-reported feedback and complaints, and communicate investigation status and corrective actions back to relevant stakeholders.
- Monitor and analyze complaint, CAPA, and non-conformance trends across all quality event streams; identify systemic issues and escalate with supporting analysis and recommended corrective actions to Quality leadership.
- Compile and present quality signals data: complaint volumes, CAPA quantities and their status, investigation outcomes, and trend analysis for management review and postmarket surveillance reporting.
- Participate in change control reviews and risk evaluations as the postmarket quality representative; provide historical complaint and CAPA data to inform risk assessments for product and process changes.
- Escalate issues to Quality leadership and serve as the Quality delegate in CAP, CLIA, NYSDOH, and FDA audit or inspection settings as appropriate.
Must Haves
- Bachelor’s degree in life sciences, clinical laboratory science, or a closely related field.
- 7+ years of quality assurance experience with direct ownership of a complaint handling or postmarket surveillance program in a regulated environment — IVD, medical device, clinical laboratory, or a combination.
- Working knowledge of CAP/CLIA laboratory complaint and quality event requirements and how they differ from FDA postmarket complaint obligations under 21 CFR 820/QMSR.
- Hands-on CAPA program experience: root cause analysis, corrective action implementation, effectiveness verification, and program-level trending.
- Demonstrated ability to mentor or develop junior quality staff — someone who builds capability in others rather than absorbing work themselves.
- Experience interfacing with external customers or commercial partners on complaint intake, communication, and resolution.
- Strong technical writing skills; ability to produce clear investigation reports, CAPA records, and trend analyses suitable for regulatory review.
- Proficiency with an electronic QMS (eQMS) platform for complaint records, CAPA tracking, and document control.
Nice To Haves
- Hands-on experience with CAP LAP inspections (COM, GEN, MOL checklists) and NYSDOH Part 58 laboratory permit requirements.
- Experience in a molecular diagnostics, cfDNA, or NGS-based testing environment.
- Familiarity with MDR evaluation under 21 CFR Part 803 in the context of an LDT/IVD organization.
- Prior experience building or formalizing complaint intake processes between a clinical laboratory and commercial partners or health system clients.
- ASQ CQA or equivalent quality certification.
Benefits And Additional Information
The US target range of our base salary for new hires is $134,425 - $170,100. You will also be eligible to receive equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered. Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education.
Freenome is proud to be an equal-opportunity employer, and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
Applicants have rights under Federal Employment Laws.
- Family & Medical Leave Act (FMLA)
- Equal Employment Opportunity (EEO)
- Employee Polygraph Protection Act (EPPA)
California applicants please review the CCPA Notice at Collection here: California Consumer Privacy Act (CCPA)
About This Opportunity
Freenome is approaching FDA approval and commercial launch of SimpleScreen™, our cfDNA-based colorectal cancer detection test. As we cross that milestone, we need a dedicated owner for the postmarket quality infrastructure that commercial launch demands — someone who can build and run a complaint handling program that works across two distinct regulatory environments. This role also owns the CAPA program — ensuring that complaints and quality events drive real corrective action, not just documentation. You will serve as the escalation point and technical mentor for junior team members managing non-conformances and laboratory incidents, and you will be the Quality interface with our commercial partners to ensure customer and partner feedback is captured, evaluated, and acted on. This is a senior individual contributor role with significant cross-functional influence and a mentorship mandate. The role reports directly to the Senior Director, Quality Assurance and is an onsite role based in our Brisbane, California headquarters.
What You’ll Do
- Own the end-to-end complaint handling process — from intake and triage through technical investigation, root cause analysis, disposition, and closure — applying the distinct regulatory requirements applicable to CAP/CLIA laboratory quality events and IVD postmarket complaints under 21 CFR 820/QMSR and ISO 13485.
- Own the CAPA program: ensure that complaints, non-conformances, and laboratory quality events drive rigorous corrective action with documented root cause analysis, implementation, and effectiveness verification. Maintain CAPA records in the eQMS with traceability required for CAP/CLIA compliance.
- Serve as the escalation point and technical mentor for junior team members managing non-conformances and laboratory incidents — coaching investigation rigor, reviewing findings, and ensuring quality events at all levels feed appropriately into the CAPA program.
- Serve as the primary Quality liaison to commercial partners and customer-facing teams as it relates to complaints and CAPA: establish and maintain processes for capturing, routing, and evaluating partner- and customer-reported feedback and complaints, and communicate investigation status and corrective actions back to relevant stakeholders.
- Monitor and analyze complaint, CAPA, and non-conformance trends across all quality event streams; identify systemic issues and escalate with supporting analysis and recommended corrective actions to Quality leadership.
- Compile and present quality signals data: complaint volumes, CAPA quantities and their status, investigation outcomes, and trend analysis for management review and postmarket surveillance reporting.
- Participate in change control reviews and risk evaluations as the postmarket quality representative; provide historical complaint and CAPA data to inform risk assessments for product and process changes.
- Escalate issues to Quality leadership and serve as the Quality delegate in CAP, CLIA, NYSDOH, and FDA audit or inspection settings as appropriate.
Must Haves
- Bachelor’s degree in life sciences, clinical laboratory science, or a closely related field.
- 7+ years of quality assurance experience with direct ownership of a complaint handling or postmarket surveillance program in a regulated environment — IVD, medical device, clinical laboratory, or a combination.
- Working knowledge of CAP/CLIA laboratory complaint and quality event requirements and how they differ from FDA postmarket complaint obligations under 21 CFR 820/QMSR.
- Hands-on CAPA program experience: root cause analysis, corrective action implementation, effectiveness verification, and program-level trending.
- Demonstrated ability to mentor or develop junior quality staff — someone who builds capability in others rather than absorbing work themselves.
- Experience interfacing with external customers or commercial partners on complaint intake, communication, and resolution.
- Strong technical writing skills; ability to produce clear investigation reports, CAPA records, and trend analyses suitable for regulatory review.
- Proficiency with an electronic QMS (eQMS) platform for complaint records, CAPA tracking, and document control.
Nice To Haves
- Hands-on experience with CAP LAP inspections (COM, GEN, MOL checklists) and NYSDOH Part 58 laboratory permit requirements.
- Experience in a molecular diagnostics, cfDNA, or NGS-based testing environment.
- Familiarity with MDR evaluation under 21 CFR Part 803 in the context of an LDT/IVD organization.
- Prior experience building or formalizing complaint intake processes between a clinical laboratory and commercial partners or health system clients.
- ASQ CQA or equivalent quality certification.
Benefits And Additional Information
The US target range of our base salary for new hires is $134,425 - $170,100. You will also be eligible to receive equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered. Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education.
Freenome is proud to be an equal-opportunity employer, and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
Applicants have rights under Federal Employment Laws.
- Family & Medical Leave Act (FMLA)
- Equal Employment Opportunity (EEO)
- Employee Polygraph Protection Act (EPPA)
California applicants please review the CCPA Notice at Collection here: California Consumer Privacy Act (CCPA)
See all 3,219+ Green Card Quality Engineer Jobs
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Get Access To All JobsTips for Finding Green Card Sponsorship as a Quality Engineer
Document your ISO and quality credentials now
PERM audits often target Quality Engineers because the role has defined industry certifications. Gather your ASQ certifications, ISO 9001 training records, and degree transcripts before you start applying so you can respond to employer credential requests quickly.
Target manufacturers enrolled in E-Verify
Employers already using E-Verify have infrastructure for employment authorization compliance, which correlates with active PERM sponsorship programs. Filter your search to companies in automotive, aerospace, and medical device sectors with established HR and immigration support.
Search green card sponsors on Migrate Mate
Use Migrate Mate to filter Quality Engineer roles by employers with active green card sponsorship history. This cuts out the guesswork of cold-applying to companies that have never filed PERM for this job category.
Clarify EB-2 versus EB-3 eligibility before offers
Quality Engineer roles typically require a bachelor's degree, qualifying under EB-3. If your role requires a master's or you hold a U.S. equivalent advanced degree, ask the employer whether they'll file under EB-2, which can improve your priority date position depending on your country of birth.
Verify your prevailing wage tier using OFLC Wage Search
DOL assigns your role a wage level from I to IV based on complexity and supervision. Your offer must meet that level for PERM certification to succeed. Check the OFLC Wage Search before negotiations so your salary aligns with what the employer will certify.
Confirm the employer understands PERM job description constraints
USCIS and DOL require the PERM job description to match your actual duties without inflating requirements. Quality Engineer postings that overstate education or experience requirements can trigger audits or denials, so confirm your employer's immigration counsel drafts the description to reflect your day-to-day work.
Green Card Quality Engineer: Frequently Asked Questions
Does a Quality Engineer role qualify for EB-2 or EB-3 sponsorship?
Most Quality Engineer positions qualify under EB-3 because they require a bachelor's degree in engineering, quality management, or a related field. EB-2 is available if the role genuinely requires a master's degree or if you have an advanced degree and your employer is willing to file under that preference category. Your country of birth determines which category offers a shorter wait given current priority dates.
How does green card sponsorship differ from H-1B sponsorship for this role?
Green card sponsorship through PERM is permanent residency, not a temporary status. There's no lottery, no six-year cap, and no annual renewal. The tradeoff is time: PERM labor certification, the I-140 petition, and the visa queue can add two to five or more years depending on your country of birth. H-1B visa gets you working faster, but it expires; EB-3 sponsorship is a path to staying permanently.
What does the PERM process actually require from a Quality Engineer candidate?
Your employer files the PERM application with DOL after completing a mandatory recruitment period. DOL verifies that no qualified U.S. workers were available for the role at the offered wage. You need to meet every requirement listed in the job posting, so your credentials, including relevant certifications and degree transcripts, must exactly match what the employer advertises during that recruitment phase.
How do I find Quality Engineer jobs where the employer already sponsors green cards?
Search for roles using Migrate Mate, which filters Quality Engineer positions by employers with documented green card sponsorship history. Applying to companies that have previously filed PERM for similar engineering roles significantly improves your chances of getting a sponsorship conversation started, since those employers already have immigration counsel and internal processes in place.
Can I change employers after my green card sponsorship starts?
Once your I-140 petition is approved and your priority date is current or within 180 days, you may be able to port your green card to a new employer in the same or similar occupational classification under AC21 portability rules. Quality Engineer roles typically transfer well because the SOC code and job duties remain consistent across manufacturers. Consult an immigration attorney before making any job change mid-process.