TN Visa Quality Auditor Jobs
Quality Auditor roles qualify for TN visa sponsorship under the USMCA treaty's Scientific Technician/Technologist category, provided your duties involve applying quality systems, inspection protocols, or auditing methodologies. Canadian citizens can apply at any port of entry or U.S. consulate; Mexican citizens apply at a U.S. consulate with an approved visa.
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Get Access To All JobsINTRODUCTION
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.
Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.
JOB SUMMARY
The Quality Auditor II reviews GLP studies for completeness, compliance, concurrence, and accuracy. The auditor provides regulatory and policy and procedural guidance. The auditor collaborates with lab personnel in design, implementation, and performance of testing with the goal of improving and building quality into the process. The auditor demonstrates proficient knowledge of quality practices and can perform job functions extending throughout the auditor’s quality audit team. Additionally, the auditor demonstrates proficiency in independent decision-making in regards to the interpretation of standards and regulations, performance of investigations, and other quality practices. The auditor has a history of successful process improvement implementation.
ESSENTIAL JOB FUNCTIONS
GLP Studies:
- Review each GLP study prior to release for testing.
- Audit a portion of each GLP study.
- Review each GLP study and final report prior to mailing.
Regulatory and Policy & Procedural Guidance:
- Know and follow GLP, GMP and relevant ISO regulations
- Perform quality event investigations and approvals
- Trend quality events
- Review and approve protocol detail sheets
- Review out of range forms
- Review discontinued studies
- Review and trend amended reports
- Review duplicate reports
- CAPA: Initiation, investigation, resolution, and verification
- Review documents in Master Control (collaboration and approval)
- Review logbooks
Process Improvement:
- Meet regularly with Section Leader, Study Directors and Lab Analysts
- Prepare Dashboard and Quarterly Management Review with Section Leader
- Audit studies in-process
- Assist Regulatory Affairs with internal audits
- Review and approve equipment qualifications and test method validations
- Perform good housekeeping (GHP) audits
- Perform other duties as assigned.
Professional Development:
- Complete required training on time (includes MasterControl, live company trainings, New Employee Orientation, etc.)
- Know and follow company policies and procedures.
EDUCATION AND EXPERIENCE REQUIREMENTS
- A.A. / A.S. and three years applicable NLI laboratory experience OR B.S. (Microbiology or biological science degree strongly preferred or NLI equivalent)
- Two years NLI applicable laboratory or quality experience in addition to demonstrated proficiency for attention to quality.
- Master trainer in job description functions.
Job Requirements
- Attention to detail
- Proficient verbal & written communication skills
- Ability to work independently
- Independent/ collaborative decision making/problem solving
- Time management- response time, meeting deadlines
- Excellent customer service/interpersonal skills
- Ability to multi-task
- Self-motivated/initiative
- Conflict management
- Follow instructions/assist others
- Presentation skills/public speaking for dashboards
- Project presentation
- Basic Algebra/ math skills
- Basic computer skills
- Dependable
Physical Requirements
Must be able to stand and walk in the lab 60% of the day and sit and type at a computer for 40% percent of the day. Lifting is minimal.
Sotera Health goes to market through its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries.
INTRODUCTION
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.
Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.
JOB SUMMARY
The Quality Auditor II reviews GLP studies for completeness, compliance, concurrence, and accuracy. The auditor provides regulatory and policy and procedural guidance. The auditor collaborates with lab personnel in design, implementation, and performance of testing with the goal of improving and building quality into the process. The auditor demonstrates proficient knowledge of quality practices and can perform job functions extending throughout the auditor’s quality audit team. Additionally, the auditor demonstrates proficiency in independent decision-making in regards to the interpretation of standards and regulations, performance of investigations, and other quality practices. The auditor has a history of successful process improvement implementation.
ESSENTIAL JOB FUNCTIONS
GLP Studies:
- Review each GLP study prior to release for testing.
- Audit a portion of each GLP study.
- Review each GLP study and final report prior to mailing.
Regulatory and Policy & Procedural Guidance:
- Know and follow GLP, GMP and relevant ISO regulations
- Perform quality event investigations and approvals
- Trend quality events
- Review and approve protocol detail sheets
- Review out of range forms
- Review discontinued studies
- Review and trend amended reports
- Review duplicate reports
- CAPA: Initiation, investigation, resolution, and verification
- Review documents in Master Control (collaboration and approval)
- Review logbooks
Process Improvement:
- Meet regularly with Section Leader, Study Directors and Lab Analysts
- Prepare Dashboard and Quarterly Management Review with Section Leader
- Audit studies in-process
- Assist Regulatory Affairs with internal audits
- Review and approve equipment qualifications and test method validations
- Perform good housekeeping (GHP) audits
- Perform other duties as assigned.
Professional Development:
- Complete required training on time (includes MasterControl, live company trainings, New Employee Orientation, etc.)
- Know and follow company policies and procedures.
EDUCATION AND EXPERIENCE REQUIREMENTS
- A.A. / A.S. and three years applicable NLI laboratory experience OR B.S. (Microbiology or biological science degree strongly preferred or NLI equivalent)
- Two years NLI applicable laboratory or quality experience in addition to demonstrated proficiency for attention to quality.
- Master trainer in job description functions.
Job Requirements
- Attention to detail
- Proficient verbal & written communication skills
- Ability to work independently
- Independent/ collaborative decision making/problem solving
- Time management- response time, meeting deadlines
- Excellent customer service/interpersonal skills
- Ability to multi-task
- Self-motivated/initiative
- Conflict management
- Follow instructions/assist others
- Presentation skills/public speaking for dashboards
- Project presentation
- Basic Algebra/ math skills
- Basic computer skills
- Dependable
Physical Requirements
Must be able to stand and walk in the lab 60% of the day and sit and type at a computer for 40% percent of the day. Lifting is minimal.
Sotera Health goes to market through its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries.
See all 198+ TN Visa Quality Auditor Jobs
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Get Access To All JobsTips for Finding TN Visa Sponsorship as a Quality Auditor
Document your auditing credentials precisely
TN visa officers scrutinize whether Quality Auditor duties qualify under the Scientific Technician category. Gather certificates like ASQ CQA or CQE, transcripts showing a technical degree, and a role description that explicitly ties your work to scientific or technical quality methodologies.
Target manufacturers with active quality systems
Automotive, aerospace, and medical device manufacturers operate under ISO 9001, AS9100, or FDA quality frameworks and routinely hire Quality Auditors who need TN sponsorship. Search by industry rather than job title alone to find employers already familiar with the classification.
Request a support letter covering your TN duties
Ask your employer to draft a TN support letter that maps your Quality Auditor responsibilities to the Scientific Technician/Technologist category. Vague letters citing only your job title are a common reason CBP officers request additional documentation at the border.
Use Migrate Mate to find sponsorship-ready employers
Many Quality Auditor postings don't advertise TN sponsorship openly. Use Migrate Mate to identify employers with recent visa filings who have sponsored work visa holders for technical roles, so you target companies already comfortable with the sponsorship process.
Understand the Mexican TN consular requirement
Mexican citizens must apply at a U.S. consulate and cannot use the Canadian port-of-entry shortcut. Schedule your DS-160 appointment well before your intended start date, since consulate wait times in major Mexican cities can extend several weeks.
Align your offer letter's listed duties with TN language
Before signing an offer, confirm the employer will describe your role using technical auditing language in the offer letter. Generic titles like 'quality specialist' without specific methodology references can complicate a CBP review, even if the actual work qualifies.
Quality Auditor TN Visa: Frequently Asked Questions
Does a Quality Auditor role qualify for TN visa sponsorship?
Quality Auditor positions can qualify under the TN visa's Scientific Technician/Technologist category when the role involves applying scientific or technical quality principles, such as ISO 9001 auditing, statistical process control, or regulatory compliance inspection. Roles focused purely on administrative quality coordination, without technical methodology, are harder to support and may be challenged at the port of entry.
How does TN visa sponsorship for Quality Auditors compare to H-1B?
TN sponsorship is faster and more predictable than H-1B visa for Quality Auditor roles. There's no lottery, no annual cap for Canadians, and Canadian citizens can get approval at a port of entry the same day. H-1B requires a March lottery registration, months of USCIS processing, and an October 1 start date. For a technical quality role that fits the Scientific Technician category, TN is almost always the faster path.
What credentials strengthen a Quality Auditor TN application?
ASQ certifications like the Certified Quality Auditor or Certified Quality Engineer carry significant weight because they demonstrate formal technical training in auditing methodology. A technical degree in engineering, sciences, or a related field also strengthens your case. CBP officers are looking for evidence that your background is genuinely technical, not just supervisory or administrative.
How do I find Quality Auditor jobs with TN visa sponsorship?
Many employers who sponsor Quality Auditor roles don't advertise it explicitly in job postings. Migrate Mate is built specifically to surface employers with TN and work visa sponsorship history for technical roles, so you can focus your applications on companies already familiar with the process rather than cold-applying to employers who may decline at the offer stage.
Can a Quality Auditor working for a staffing agency use TN status?
TN status through a staffing agency is possible but adds complexity. The agency must be the employer of record, meaning they sponsor the TN, not the end client. CBP will scrutinize whether the agency or the client site controls your work. If the end client directs your day-to-day duties, USCIS may view the arrangement as the client being the true employer, which can create compliance issues.