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 Office Hours (40/wk)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. As part of our team, you’ll help enable our customers to make the world healthier, cleaner, and safer.
The Sr. Quality Program Manager, Customer Defect Tracking & Resolution will lead the global intake, triage, tracking, escalation, and communication of customer-reported defects and quality issues. This role is responsible for ensuring a robust, compliant, and scalable process aligned with Thermo Fisher’s Quality Management System (QMS), applicable regulatory requirements (e.g., FDA, ISO), and customer expectations.
The successful candidate will bring strong technical expertise in quality or manufacturing engineering, combined with leadership capabilities to drive cross-functional collaboration, timely issue resolution, and continuous improvement.
Key Responsibilities
Quality & Compliance Leadership
- Ensure all customer defect tracking and resolution activities comply with Thermo Fisher’s QMS, including alignment with CAPA, complaint handling, and escalation processes.
- Maintain compliance with applicable global regulatory requirements (e.g., FDA 21 CFR Part 820/210/211, ISO 13485, ISO 9001, as applicable).
- Support audit readiness and participate in internal and external audits related to customer complaints and defect management.
Customer Issue Intake & Case Management
- Lead the daily intake and documentation of customer-reported defects across multiple channels.
- Ensure accurate and complete case creation, including assignment of unique identifiers and proper documentation within approved systems.
- Establish and maintain standardized severity classification criteria to assess risk and customer impact.
Triage, Escalation & Prioritization
- Evaluate and triage incoming issues to determine appropriate escalation pathways and urgency.
- Assign severity levels and prioritize cases based on product risk, regulatory impact, and customer criticality.
- Drive immediate response and visibility for high-severity or critical escalations.
Cross-Functional Coordination & Ownership
- Assign case ownership to appropriate functions (e.g., Quality, Manufacturing, R&D, Supply Chain, Customer Support).
- Lead cross-functional collaboration to ensure timely investigation, root cause analysis, and resolution.
- Track progress, ensure accountability, and proactively remove barriers to resolution.
Communication & Stakeholder Engagement
- Serve as the central point of coordination for customer defect communications.
- Ensure consistent, accurate, and timely communication across internal stakeholders and customer-facing teams.
- Consolidate communications for similar or recurring issues to maintain alignment and clarity.
- Provide regular status updates to leadership and stakeholders on open and critical cases.
Data Analytics & Continuous Improvement
- Develop and monitor key performance indicators (KPIs), including response time, resolution time, backlog, and recurrence trends.
- Analyze defect data to identify systemic issues and drive preventive actions.
- Partner with Quality and Engineering teams to implement corrective and preventive actions (CAPA).
- Drive process improvements to enhance efficiency, compliance, and customer experience.
Minimum Qualifications (Basic Requirements)
- Bachelor’s degree in Engineering (Quality, Manufacturing, Mechanical, Industrial, or related discipline).
- 7+ years of experience in quality engineering, manufacturing engineering, or a related technical field.
- Demonstrated experience managing customer complaints, defect tracking systems, or escalation processes within a regulated environment.
- Strong knowledge of Quality Management Systems (QMS), including CAPA, root cause analysis (RCA), and risk management tools (e.g., FMEA).
- Proven ability to lead cross-functional teams and manage multiple priorities in a fast-paced environment.
Preferred Qualifications
- Experience in life sciences, medical devices, diagnostics, or pharmaceutical manufacturing environments.
- Familiarity with complaint handling and regulatory reporting requirements (e.g., MDR, vigilance reporting).
- Experience with case management or defect tracking systems (e.g., Salesforce, ServiceNow, TrackWise, Jira).
- Lean Six Sigma certification (Green Belt or Black Belt) or equivalent continuous improvement training.
- Experience supporting regulatory inspections and audits.
Knowledge, Skills, Abilities
- Strong analytical and problem-solving capabilities with attention to detail.
- Excellent written and verbal communication skills, including the ability to communicate complex issues clearly to diverse audiences.
- Ability to assess risk and make sound decisions under pressure.
- Strong organizational skills with the ability to manage multiple high-impact issues simultaneously.
- Demonstrated leadership and influencing skills in a matrixed organization.
- Continuous improvement mindset with a focus on operational excellence and customer satisfaction.
- May require occasional travel (up to 20%).
Our Mission is to enable our customers to make the world healthier, cleaner, and safer.
As one team of 100,000+ colleagues, we share a common set of values – Integrity, Intensity, Innovation, and Involvement – working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need.
Compensation and Benefits
The salary range estimated for this position based in New York is $118,100.00–$177,200.00. 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 Office Hours (40/wk)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. As part of our team, you’ll help enable our customers to make the world healthier, cleaner, and safer.
The Sr. Quality Program Manager, Customer Defect Tracking & Resolution will lead the global intake, triage, tracking, escalation, and communication of customer-reported defects and quality issues. This role is responsible for ensuring a robust, compliant, and scalable process aligned with Thermo Fisher’s Quality Management System (QMS), applicable regulatory requirements (e.g., FDA, ISO), and customer expectations.
The successful candidate will bring strong technical expertise in quality or manufacturing engineering, combined with leadership capabilities to drive cross-functional collaboration, timely issue resolution, and continuous improvement.
Key Responsibilities
Quality & Compliance Leadership
- Ensure all customer defect tracking and resolution activities comply with Thermo Fisher’s QMS, including alignment with CAPA, complaint handling, and escalation processes.
- Maintain compliance with applicable global regulatory requirements (e.g., FDA 21 CFR Part 820/210/211, ISO 13485, ISO 9001, as applicable).
- Support audit readiness and participate in internal and external audits related to customer complaints and defect management.
Customer Issue Intake & Case Management
- Lead the daily intake and documentation of customer-reported defects across multiple channels.
- Ensure accurate and complete case creation, including assignment of unique identifiers and proper documentation within approved systems.
- Establish and maintain standardized severity classification criteria to assess risk and customer impact.
Triage, Escalation & Prioritization
- Evaluate and triage incoming issues to determine appropriate escalation pathways and urgency.
- Assign severity levels and prioritize cases based on product risk, regulatory impact, and customer criticality.
- Drive immediate response and visibility for high-severity or critical escalations.
Cross-Functional Coordination & Ownership
- Assign case ownership to appropriate functions (e.g., Quality, Manufacturing, R&D, Supply Chain, Customer Support).
- Lead cross-functional collaboration to ensure timely investigation, root cause analysis, and resolution.
- Track progress, ensure accountability, and proactively remove barriers to resolution.
Communication & Stakeholder Engagement
- Serve as the central point of coordination for customer defect communications.
- Ensure consistent, accurate, and timely communication across internal stakeholders and customer-facing teams.
- Consolidate communications for similar or recurring issues to maintain alignment and clarity.
- Provide regular status updates to leadership and stakeholders on open and critical cases.
Data Analytics & Continuous Improvement
- Develop and monitor key performance indicators (KPIs), including response time, resolution time, backlog, and recurrence trends.
- Analyze defect data to identify systemic issues and drive preventive actions.
- Partner with Quality and Engineering teams to implement corrective and preventive actions (CAPA).
- Drive process improvements to enhance efficiency, compliance, and customer experience.
Minimum Qualifications (Basic Requirements)
- Bachelor’s degree in Engineering (Quality, Manufacturing, Mechanical, Industrial, or related discipline).
- 7+ years of experience in quality engineering, manufacturing engineering, or a related technical field.
- Demonstrated experience managing customer complaints, defect tracking systems, or escalation processes within a regulated environment.
- Strong knowledge of Quality Management Systems (QMS), including CAPA, root cause analysis (RCA), and risk management tools (e.g., FMEA).
- Proven ability to lead cross-functional teams and manage multiple priorities in a fast-paced environment.
Preferred Qualifications
- Experience in life sciences, medical devices, diagnostics, or pharmaceutical manufacturing environments.
- Familiarity with complaint handling and regulatory reporting requirements (e.g., MDR, vigilance reporting).
- Experience with case management or defect tracking systems (e.g., Salesforce, ServiceNow, TrackWise, Jira).
- Lean Six Sigma certification (Green Belt or Black Belt) or equivalent continuous improvement training.
- Experience supporting regulatory inspections and audits.
Knowledge, Skills, Abilities
- Strong analytical and problem-solving capabilities with attention to detail.
- Excellent written and verbal communication skills, including the ability to communicate complex issues clearly to diverse audiences.
- Ability to assess risk and make sound decisions under pressure.
- Strong organizational skills with the ability to manage multiple high-impact issues simultaneously.
- Demonstrated leadership and influencing skills in a matrixed organization.
- Continuous improvement mindset with a focus on operational excellence and customer satisfaction.
- May require occasional travel (up to 20%).
Our Mission is to enable our customers to make the world healthier, cleaner, and safer.
As one team of 100,000+ colleagues, we share a common set of values – Integrity, Intensity, Innovation, and Involvement – working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need.
Compensation and Benefits
The salary range estimated for this position based in New York is $118,100.00–$177,200.00. 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.