Green Card Lead Quality Engineer Jobs
Lead Quality Engineer jobs with green card sponsorship require employers to complete PERM labor certification with the Department of Labor before filing an I-140 petition with USCIS. EB-2 applies if your role requires an advanced degree; EB-3 covers bachelor's-level professionals. Per-country priority-date backlogs vary, so starting the sponsorship process early matters.
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Get Access To All JobsWork Schedule
First Shift (Days)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Site Quality Lead / Staff Quality Engineer
R-01364732
Guilford, CT (site based)
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Clinical Next Generation Sequencing Division (CSD) provides sample-to-answer instruments, software, and reagent solutions. CSD is the market leader in targeted sequencing and clinical next-generation sequencing and holds a leading position in research markets.
The Staff Quality Engineer serves as the Site Quality Lead and a member of the Site Leadership Team, providing strategic quality leadership across the product lifecycle. This role enables compliant innovation, drives continuous improvement, and ensures an effective Quality Management System supporting the site's responsibilities as an FDA-registered Specification Developer. This role combines strategic leadership with hands-on ownership of the site's Quality Management System and core quality processes, requiring the ability to effectively balance long-term quality strategy with day-to-day operational execution.
The role collaborates closely with Global Design Quality, Research & Development, Supplier Quality, and Operations to drive product quality improvements across the product lifecycle, achieve site quality objectives, and ensure quality is integrated into product and process decisions while maintaining an inspection-ready state and enabling compliant innovation.
- Own the effectiveness of the site's Quality Management System, establishing priorities, balancing strategic initiatives with operational support, and ensuring compliance with applicable regulatory and corporate quality requirements.
- Serve as the site's Management Representative, leading Management Review activities and communicating the health, performance, and effectiveness of the Quality Management System through meaningful quality metrics.
- Provide strategic Quality leadership across the product lifecycle, from product development through commercialization and post-launch support, ensuring quality is designed into products, integrated into business decisions, and continuously improved through customer feedback and operational performance.
- Leverage quality system, product performance, customer feedback, complaint trends, and post-market data to identify emerging risks, drive systemic improvements, and influence product and process decisions across the product lifecycle.
- Partner with Global Design Quality, Manufacturing, Supplier Quality, Regulatory Affairs, and cross-functional teams to ensure the site fulfills its responsibilities as an FDA-registered Specification Developer and to drive alignment across product requirements, supplier performance, and manufacturing readiness.
- Own the execution and continuous improvement of site Quality System processes, including CAPA, deviations, change control, document control, training, internal audits, and Management Review, ensuring ongoing compliance and inspection readiness.
- Drive strategic quality improvements by identifying systemic risks, simplifying quality processes, and using quality metrics to influence business decisions and continuous improvement initiatives.
- Partner with cross-functional teams to establish robust quality requirements, qualification strategies, supplier capabilities, inspection methods, and process controls that drive defect prevention and improve product quality throughout the product lifecycle.
- Provide independent quality guidance and risk-based decision making to support compliant product development while enabling innovation and business objectives.
- Represent the site during internal, customer, and regulatory inspections, ensuring timely and effective responses to audit observations.
- Promote a proactive quality culture by influencing cross-functional teams, coaching quality best practices, and fostering accountability across the organization.
- Contribute as a member of the Site Leadership Team by influencing site strategy, operational excellence, resource prioritization, and business decisions through the lens of Quality.
Education:
- Bachelor's degree in Engineering, Life Sciences, or related scientific discipline.
Experience:
- 8+ years of Quality experience in the medical device, IVD, biotechnology, or pharmaceutical industry.
- Demonstrated experience supporting Design Controls and product development.
- Demonstrated experience implementing and maintaining Quality Management Systems within a regulated medical device, IVD, or biotechnology environment, including knowledge of ISO 13485, FDA QMSR, Design Controls, and Risk Management.
Knowledge, Skills, Abilities:
- Demonstrated ability to influence cross-functional teams and lead initiatives without direct authority.
- Experience leading Quality System processes, including CAPA, audits, change control, and regulatory inspections.
- Strong analytical, communication, and problem-solving skills.
Preferred Qualifications
- Experience supporting complex instrument development and commercialization.
- Experience working with contract manufacturers, supplier quality organizations, or complex supply chains.
- Knowledge of APQP, PPAP, FMEA, MSA, SPC, or other advanced quality methodologies.
- ASQ Certified Quality Engineer (CQE) or equivalent certification.
Compensation and Benefits
The salary range estimated for this position based in Connecticut is $103,100.00–$150,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
- A choice of national medical and dental plans, and a national vision plan, including health incentive programs
- Employee assistance and family support programs, including commuter benefits and tuition reimbursement
- At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
Work Schedule
First Shift (Days)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Site Quality Lead / Staff Quality Engineer
R-01364732
Guilford, CT (site based)
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Clinical Next Generation Sequencing Division (CSD) provides sample-to-answer instruments, software, and reagent solutions. CSD is the market leader in targeted sequencing and clinical next-generation sequencing and holds a leading position in research markets.
The Staff Quality Engineer serves as the Site Quality Lead and a member of the Site Leadership Team, providing strategic quality leadership across the product lifecycle. This role enables compliant innovation, drives continuous improvement, and ensures an effective Quality Management System supporting the site's responsibilities as an FDA-registered Specification Developer. This role combines strategic leadership with hands-on ownership of the site's Quality Management System and core quality processes, requiring the ability to effectively balance long-term quality strategy with day-to-day operational execution.
The role collaborates closely with Global Design Quality, Research & Development, Supplier Quality, and Operations to drive product quality improvements across the product lifecycle, achieve site quality objectives, and ensure quality is integrated into product and process decisions while maintaining an inspection-ready state and enabling compliant innovation.
- Own the effectiveness of the site's Quality Management System, establishing priorities, balancing strategic initiatives with operational support, and ensuring compliance with applicable regulatory and corporate quality requirements.
- Serve as the site's Management Representative, leading Management Review activities and communicating the health, performance, and effectiveness of the Quality Management System through meaningful quality metrics.
- Provide strategic Quality leadership across the product lifecycle, from product development through commercialization and post-launch support, ensuring quality is designed into products, integrated into business decisions, and continuously improved through customer feedback and operational performance.
- Leverage quality system, product performance, customer feedback, complaint trends, and post-market data to identify emerging risks, drive systemic improvements, and influence product and process decisions across the product lifecycle.
- Partner with Global Design Quality, Manufacturing, Supplier Quality, Regulatory Affairs, and cross-functional teams to ensure the site fulfills its responsibilities as an FDA-registered Specification Developer and to drive alignment across product requirements, supplier performance, and manufacturing readiness.
- Own the execution and continuous improvement of site Quality System processes, including CAPA, deviations, change control, document control, training, internal audits, and Management Review, ensuring ongoing compliance and inspection readiness.
- Drive strategic quality improvements by identifying systemic risks, simplifying quality processes, and using quality metrics to influence business decisions and continuous improvement initiatives.
- Partner with cross-functional teams to establish robust quality requirements, qualification strategies, supplier capabilities, inspection methods, and process controls that drive defect prevention and improve product quality throughout the product lifecycle.
- Provide independent quality guidance and risk-based decision making to support compliant product development while enabling innovation and business objectives.
- Represent the site during internal, customer, and regulatory inspections, ensuring timely and effective responses to audit observations.
- Promote a proactive quality culture by influencing cross-functional teams, coaching quality best practices, and fostering accountability across the organization.
- Contribute as a member of the Site Leadership Team by influencing site strategy, operational excellence, resource prioritization, and business decisions through the lens of Quality.
Education:
- Bachelor's degree in Engineering, Life Sciences, or related scientific discipline.
Experience:
- 8+ years of Quality experience in the medical device, IVD, biotechnology, or pharmaceutical industry.
- Demonstrated experience supporting Design Controls and product development.
- Demonstrated experience implementing and maintaining Quality Management Systems within a regulated medical device, IVD, or biotechnology environment, including knowledge of ISO 13485, FDA QMSR, Design Controls, and Risk Management.
Knowledge, Skills, Abilities:
- Demonstrated ability to influence cross-functional teams and lead initiatives without direct authority.
- Experience leading Quality System processes, including CAPA, audits, change control, and regulatory inspections.
- Strong analytical, communication, and problem-solving skills.
Preferred Qualifications
- Experience supporting complex instrument development and commercialization.
- Experience working with contract manufacturers, supplier quality organizations, or complex supply chains.
- Knowledge of APQP, PPAP, FMEA, MSA, SPC, or other advanced quality methodologies.
- ASQ Certified Quality Engineer (CQE) or equivalent certification.
Compensation and Benefits
The salary range estimated for this position based in Connecticut is $103,100.00–$150,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
- A choice of national medical and dental plans, and a national vision plan, including health incentive programs
- Employee assistance and family support programs, including commuter benefits and tuition reimbursement
- At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
See all 234+ Green Card Lead Quality Engineer Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Green Card Lead Quality Engineer Jobs.
Get Access To All JobsTips for Finding Green Card Sponsorship as a Lead Quality Engineer
Align your credentials to EB category
Pull your official transcripts and performance review records before applying. EB-2 requires an advanced degree or a bachelor's plus five years of progressive experience in quality engineering. Document each promotion and scope expansion separately so your employer can build a clean PERM case.
Target employers with active PERM filings
Search Migrate Mate to find employers who have filed PERM labor certifications for quality engineering roles. Focusing on companies with a filing history in your target SOC code tells you they already understand the recruitment test and prevailing wage obligations.
Verify prevailing wage tier before negotiating
Use the OFLC Wage Search to look up the prevailing wage for your occupation code and work location before you receive an offer. PERM locks the offered salary to that wage level, so knowing the floor in advance helps you negotiate without creating a compliance problem for the employer.
Ask employers about their PERM recruitment timeline
PERM requires DOL-compliant job postings, internal notice, and a recruitment report before filing. That process typically takes several months. Ask hiring managers early whether they sponsor green cards and how far along any active recruitment tests are for the role you're interviewing for.
Check your priority date against the Visa Bulletin
Once your employer files the I-140, your priority date is set. If you're a national of India or China, the State Department's Visa Bulletin determines when you can file for adjustment of status. Track both the Final Action Date and the Dates for Filing chart each month.
Understand AC21 portability before switching jobs
If you change employers after your I-485 has been pending for at least 180 days, AC21 portability lets you keep your place in line if the new Lead Quality Engineer role is in the same or a substantially similar occupation. Confirm the SOC code alignment with your new employer before resigning.
Green Card Lead Quality Engineer: Frequently Asked Questions
How does green card sponsorship for a Lead Quality Engineer differ from H-1B sponsorship?
Green card sponsorship leads to lawful permanent residence, not temporary status. For Lead Quality Engineers, the process starts with PERM labor certification filed with the Department of Labor, which requires a prevailing wage determination and a formal recruitment test. After PERM is certified, the employer files an I-140 petition with USCIS. Unlike H-1B visa, there is no lottery, but per-country annual limits create priority-date backlogs for nationals of high-demand countries like India and China.
Which EB category applies to Lead Quality Engineers?
Most Lead Quality Engineer roles qualify under EB-2 if the position genuinely requires an advanced degree or a bachelor's degree plus five years of progressive experience in quality engineering or a closely related field. EB-3 applies when the role requires a bachelor's degree and at least two years of experience. Your employer's attorney will determine the category based on the actual minimum requirements of the position, not your personal qualifications alone.
How do I find employers who sponsor green cards for Lead Quality Engineer roles?
Migrate Mate lists employers with verified PERM filing history searchable by occupation and location, so you can identify companies that have already navigated the DOL labor certification process for quality engineering roles. Targeting these employers is more efficient than approaching companies with no PERM experience, since those employers already understand prevailing wage obligations and recruitment test requirements.
What does the PERM recruitment test mean for my job search as a foreign professional?
PERM requires your employer to demonstrate to DOL that no minimally qualified U.S. worker is available for the role. The employer posts the position through several channels, including a job order with the State Workforce Agency, newspaper ads, and an internal notice. As a foreign candidate, you should expect this process to run in parallel with your hiring, and you won't start the green card clock until PERM is filed after recruitment concludes.
Can I keep my green card sponsorship if I change jobs as a Lead Quality Engineer?
AC21 job portability protects your place in line if your I-485 has been pending for at least 180 days and you move to the same or a substantially similar occupation. Lead Quality Engineer roles generally share the same SOC code, so a lateral move within quality engineering typically qualifies. Your approved I-140 priority date can also carry over to a new employer's I-140 petition, but confirm both conditions with an immigration attorney before resigning.