Quality Engineer Jobs at Thermo Fisher Scientific with Visa Sponsorship
Quality Engineer jobs at Thermo Fisher Scientific sit at the intersection of regulatory compliance and scientific manufacturing, covering everything from incoming inspection to CAPA management across life sciences and diagnostics. Thermo Fisher has a consistent track record of sponsoring international candidates for quality-focused engineering positions.
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Get Access To All JobsWork Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office
Position Summary
The Director of Quality - Biologicals and Chemicals Division provides global quality leadership across the Cell Culture Media Network, spanning multiple manufacturing sites (e.g., Grand Island, Inchinnan, Miami). Reporting to the Sr. Director of Quality, this role is accountable for the performance, compliance, and continuous improvement of the Manufacturing Quality function across the network. The Director ensures consistent application of Quality Management Systems, ensures product quality, drives harmonization across sites, and aligns quality strategy with business objectives, customer expectations, and regulatory requirements.
Key Responsibilities
- Lead and execute the network-wide Manufacturing Quality strategy aligned with BCD Quality operating model
- Provide end-to-end Quality leadership across multiple manufacturing sites, ensuring compliance to ISO 13485, FDA 21 CFR 820, MDSAP, and applicable global standards
- Drive harmonization and standardization of Quality processes, systems, and metrics across the network
- Own network product Quality performance, including primary KPIs related to complaints, cost of poor quality (COPQ), and manufacturing health, and other metrics as required to ensure the health of manufacturing quality processes
- Lead and develop a global team across Quality Engineering, QMS, laboratories, and product release functions
- Partner with Operations, R&D, Regulatory Affairs, and Commercial teams to ensure successful product lifecycle management
- Drive proactive quality engineering strategies and continuous improvement initiatives (e.g., Lean Six Sigma)
- Oversee and govern complaint and nonconformance management across the media network sites
- Serve as escalation point for critical quality issues and ensure timely containment and resolution
- Lead customer and regulatory interactions, including audits, inspections, and issue resolution
- Enable execution readiness for regional capacity expansion and new product introductions
- Establish and maintain a strong culture of quality, accountability, and continuous improvement across the network
Leadership & Governance
Maintain centralized Quality governance across the network while supporting site-level execution through matrix leadership. Ensure consistent decision-making, escalation pathways, and performance management across regions. Drive Management Review processes at network level and ensure alignment with enterprise quality objectives.
Qualifications
- Bachelor’s degree in Science, Engineering, or related field (advanced degree preferred)
- 10+ years of Quality experience in regulated industries
- 5+ years of leadership experience in multi-site or global quality organizations
- Deep knowledge of GMP, ISO standards, FDA regulations, and global quality systems
- Demonstrated experience leading cross-functional and multi-site initiatives
- Strong leadership, communication, and decision-making skills
- Experience in continuous improvement methodologies (Six Sigma, Lean)
- Ability to operate in a global, matrixed organization
Compensation and Benefits
The salary range estimated for this position based in New York is $175,000.00–$205,000.00. 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
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office
Position Summary
The Director of Quality - Biologicals and Chemicals Division provides global quality leadership across the Cell Culture Media Network, spanning multiple manufacturing sites (e.g., Grand Island, Inchinnan, Miami). Reporting to the Sr. Director of Quality, this role is accountable for the performance, compliance, and continuous improvement of the Manufacturing Quality function across the network. The Director ensures consistent application of Quality Management Systems, ensures product quality, drives harmonization across sites, and aligns quality strategy with business objectives, customer expectations, and regulatory requirements.
Key Responsibilities
- Lead and execute the network-wide Manufacturing Quality strategy aligned with BCD Quality operating model
- Provide end-to-end Quality leadership across multiple manufacturing sites, ensuring compliance to ISO 13485, FDA 21 CFR 820, MDSAP, and applicable global standards
- Drive harmonization and standardization of Quality processes, systems, and metrics across the network
- Own network product Quality performance, including primary KPIs related to complaints, cost of poor quality (COPQ), and manufacturing health, and other metrics as required to ensure the health of manufacturing quality processes
- Lead and develop a global team across Quality Engineering, QMS, laboratories, and product release functions
- Partner with Operations, R&D, Regulatory Affairs, and Commercial teams to ensure successful product lifecycle management
- Drive proactive quality engineering strategies and continuous improvement initiatives (e.g., Lean Six Sigma)
- Oversee and govern complaint and nonconformance management across the media network sites
- Serve as escalation point for critical quality issues and ensure timely containment and resolution
- Lead customer and regulatory interactions, including audits, inspections, and issue resolution
- Enable execution readiness for regional capacity expansion and new product introductions
- Establish and maintain a strong culture of quality, accountability, and continuous improvement across the network
Leadership & Governance
Maintain centralized Quality governance across the network while supporting site-level execution through matrix leadership. Ensure consistent decision-making, escalation pathways, and performance management across regions. Drive Management Review processes at network level and ensure alignment with enterprise quality objectives.
Qualifications
- Bachelor’s degree in Science, Engineering, or related field (advanced degree preferred)
- 10+ years of Quality experience in regulated industries
- 5+ years of leadership experience in multi-site or global quality organizations
- Deep knowledge of GMP, ISO standards, FDA regulations, and global quality systems
- Demonstrated experience leading cross-functional and multi-site initiatives
- Strong leadership, communication, and decision-making skills
- Experience in continuous improvement methodologies (Six Sigma, Lean)
- Ability to operate in a global, matrixed organization
Compensation and Benefits
The salary range estimated for this position based in New York is $175,000.00–$205,000.00. 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 Quality Engineer Jobs at Thermo Fisher Scientific
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Quality Engineer Jobs at Thermo Fisher Scientific.
Get Access To All JobsTips for Finding Quality Engineer Jobs at Thermo Fisher Scientific
Align your credentials to FDA-regulated environments
Thermo Fisher's Quality Engineer roles in life sciences and diagnostics require familiarity with FDA 21 CFR Part 820 and ISO 13485. Documenting hands-on experience with these standards on your resume directly matches what hiring managers screen for.
Target sites with active manufacturing operations
Thermo Fisher's sponsorship activity for Quality Engineers clusters around its manufacturing and production facilities, not corporate offices. Search by location for sites in states like Massachusetts, Pennsylvania, and California where regulated manufacturing runs continuously.
Browse open Quality Engineer roles on Migrate Mate
Use Migrate Mate to filter Quality Engineer openings at Thermo Fisher Scientific by visa type, so you only see roles where sponsorship is confirmed. This removes the guesswork before you invest time in a full application.
Clarify your OPT or CPT timeline during screening
If you're on F-1 OPT, tell the recruiter your authorization end date and STEM extension eligibility upfront. Quality Engineer roles often take 60 to 90 days to fill, and Thermo Fisher needs that lead time to align filing deadlines with your start date.
Understand how TN status works for this role
Canadian and Mexican nationals can qualify for TN status under the engineer category if the Quality Engineer role requires a relevant bachelor's degree. Confirm with your hiring contact that the job description lists a specific engineering or science degree requirement, since TN adjudicators scrutinize this closely.
Confirm PERM sponsorship intent before accepting an offer
For Green Card sponsorship through EB-2 or EB-3, Thermo Fisher typically initiates PERM labor certification after you've established a performance record. Ask explicitly during offer negotiation whether the role is eligible for immigrant visa sponsorship and what the expected timeline looks like.
Frequently Asked Questions
Does Thermo Fisher Scientific sponsor H-1B visas for Quality Engineers?
Yes, Thermo Fisher Scientific sponsors H-1B visas for Quality Engineer positions. The company participates in the H-1B cap lottery each April and also files cap-exempt petitions for qualifying facilities. Because Quality Engineer roles require a specific technical degree, they generally satisfy USCIS specialty occupation requirements, which strengthens the petition.
Which visa types are commonly used for Quality Engineer roles at Thermo Fisher Scientific?
H-1B is the most common route for Quality Engineers at Thermo Fisher. F-1 OPT and CPT are used for recent graduates entering quality roles, with STEM OPT extensions available for qualifying degree holders. TN visa status is an option for Canadian and Mexican nationals in engineering classifications, and Green Card sponsorship via EB-2 or EB-3 is available for longer-term employees.
What qualifications does Thermo Fisher Scientific expect for Quality Engineer roles?
Most Quality Engineer postings at Thermo Fisher require a bachelor's degree in engineering, life sciences, or a closely related field. Practical experience with quality management systems, nonconformance handling, and root cause analysis is standard. Familiarity with ISO 13485, FDA 21 CFR Part 820, or GMP environments is a strong differentiator, particularly for roles in medical devices or bioproduction.
How do I apply for Quality Engineer jobs at Thermo Fisher Scientific?
You can search and apply through Thermo Fisher's careers portal directly. To focus specifically on roles that include visa sponsorship, use Migrate Mate to browse verified Quality Engineer openings at Thermo Fisher filtered by visa type. Applications typically require a resume, and some postings ask for a brief cover letter outlining relevant quality systems experience.
How do I manage the timing between my visa status and a Quality Engineer offer at Thermo Fisher Scientific?
Timing is the most common friction point for international candidates. If you're on OPT, confirm how many months of authorization remain and whether your degree qualifies for a STEM extension, which provides up to 24 additional months. For H-1B, petitions filed under the cap have an October 1 start date, so offers extended in spring need a gap plan or an OPT bridge. Raise this with your recruiter early.