H-1B Visa Quality Assurance Auditor Jobs
Quality Assurance Auditor roles qualify for H-1B visa sponsorship as specialty occupations requiring at least a bachelor's degree in quality management, engineering, or a related field. Employers in manufacturing, pharmaceuticals, medical devices, and aerospace regularly file LCAs for these positions, making them a reliable target for H-1B candidates.
Find H-1B Visa Quality Assurance Auditor JobsOverview
Showing 5 of 60+ Quality Assurance Auditor jobs
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
See all 60+ Quality Assurance Auditor Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Quality Assurance Auditor roles.
Get Access To All JobsLocation: Durham, United States of America
Job Type: Full time
Overview:
Plan and conduct independent clinical (GCP) audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to supervisor, operations staff, management, and customers. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.
Essential Functions:
- Plan, schedule, conduct, report and close audit activities in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations/guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions
- Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers
- Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures
- Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans
- Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closure for quality events arising from Audits; and from Quality Issues, Inspections or during similar QA activities as assigned
- Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
- Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle
- Lead/collaborate/support in QA initiatives/projects for quality, process improvements
- Assist in training of new Quality Assurance staff
- May be required to manage Quality Issues
- May present educational programs and provide guidance to operational staff on compliance procedures
- May perform pre-inspection visits at sites, host audits/inspections; ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections, as assigned
Qualifications
- Bachelor's Degree Pref
- Travel 30-50%
- 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance Audits. GCP experience. Equivalent combination of education, training and experience
- Experienced in the conduct of clinical trial Investigator site audits
- Experience in the conduct of clinical study report/data management/biostatistics clinical trial audits is preferred
- Knowledge of word-processing, spreadsheet, and database applications
- Extensive knowledge of pharmaceutical research and development processes and regulatory environments
- Knowledge of quality assurance processes and procedures
- Strong interpersonal skills
- Excellent problem solving, risk analysis and negotiation skills
- Strong training capabilities
- Effective organization, communication, and team orientation skills
- Ability to initiate assigned tasks and to work independently
- Ability to manage multiple projects
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is $75,400.00 - $188,600.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Location: Durham, United States of America
Job Type: Full time
Overview:
Plan and conduct independent clinical (GCP) audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to supervisor, operations staff, management, and customers. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.
Essential Functions:
- Plan, schedule, conduct, report and close audit activities in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations/guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions
- Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers
- Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures
- Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans
- Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closure for quality events arising from Audits; and from Quality Issues, Inspections or during similar QA activities as assigned
- Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
- Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle
- Lead/collaborate/support in QA initiatives/projects for quality, process improvements
- Assist in training of new Quality Assurance staff
- May be required to manage Quality Issues
- May present educational programs and provide guidance to operational staff on compliance procedures
- May perform pre-inspection visits at sites, host audits/inspections; ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections, as assigned
Qualifications
- Bachelor's Degree Pref
- Travel 30-50%
- 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance Audits. GCP experience. Equivalent combination of education, training and experience
- Experienced in the conduct of clinical trial Investigator site audits
- Experience in the conduct of clinical study report/data management/biostatistics clinical trial audits is preferred
- Knowledge of word-processing, spreadsheet, and database applications
- Extensive knowledge of pharmaceutical research and development processes and regulatory environments
- Knowledge of quality assurance processes and procedures
- Strong interpersonal skills
- Excellent problem solving, risk analysis and negotiation skills
- Strong training capabilities
- Effective organization, communication, and team orientation skills
- Ability to initiate assigned tasks and to work independently
- Ability to manage multiple projects
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is $75,400.00 - $188,600.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
See all 60+ H-1B Visa Quality Assurance Auditor Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Quality Assurance Auditor Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Quality Assurance Auditor
Verify your degree supports specialty occupation
H-1B approval depends on your degree field matching the QA Auditor role. A degree in industrial engineering, chemistry, or quality systems is a stronger fit than a general business degree. Check O*NET for the occupation's accepted education pathways before applying.
Target regulated industries with audit mandates
Pharmaceutical, medical device, aerospace, and food manufacturing employers file H-1B petitions for QA Auditors consistently because FDA and ISO compliance requires credentialed specialists. Focusing your search on these sectors raises your chances of finding active sponsorship.
Search verified H-1B sponsors on Migrate Mate
Filter your job search on Migrate Mate by employers with confirmed H-1B LCA filing history for QA and quality engineering roles. That data comes from DOL disclosures, so you're targeting companies with a documented record of sponsoring this occupation.
Confirm LCA wage level before accepting an offer
Your employer's LCA must certify a prevailing wage at Level I through IV. Use the OFLC Wage Search to look up the certified wage for your SOC code and work location before signing, so there are no surprises during USCIS adjudication.
Time your offer around the H-1B cap window
USCIS only accepts H-1B cap registrations in March for an October 1 start date. If you receive an offer outside that window, ask your employer whether a cap-exempt entity such as a university or nonprofit research organization is involved in the role.
Document audit certifications for the H-1B petition
Credentials like ASQ Certified Quality Auditor or ISO 9001 Lead Auditor strengthen your employer's specialty occupation argument in the I-129 petition. Gather official certificates and transcripts early, since USCIS may request these in a Request for Evidence.
H-1B Visa Quality Assurance Auditor: Frequently Asked Questions
Does a Quality Assurance Auditor role qualify as a specialty occupation for H-1B purposes?
Yes, provided the employer can show the position normally requires at least a bachelor's degree in a specific related field such as quality engineering, industrial engineering, chemistry, or life sciences. Generalist roles where any degree is accepted can face scrutiny, so the job description should explicitly tie duties to a specialized field of study.
Which industries sponsor H-1B visas most consistently for QA Auditor positions?
Pharmaceutical manufacturers, medical device companies, aerospace contractors, and food and beverage producers are among the most active H-1B sponsors for QA Auditors. These industries operate under strict regulatory frameworks from the FDA, FAA, and ISO bodies that require credentialed audit professionals, making H-1B sponsorship a practical business necessity rather than an exception.
How do I find employers actively sponsoring H-1B visas for Quality Assurance Auditor roles?
Search on Migrate Mate, which surfaces employers with verified LCA filing history for QA and quality engineering occupations using DOL disclosure data. This filters out employers who say they sponsor but have no documented filings, saving you time on applications that are unlikely to lead to a petition.
Can professional certifications like CQA or ISO Lead Auditor help my H-1B petition?
They can, but they don't substitute for a qualifying degree. USCIS evaluates specialty occupation based on the degree requirement, not certifications alone. That said, holding an ASQ Certified Quality Auditor or ISO 9001 Lead Auditor credential reinforces the argument that the role requires specialized knowledge and can help counter a Request for Evidence if your degree field is adjacent rather than directly aligned.
What happens to my H-1B status if my employer loses a major audit contract and my role changes?
A material change in job duties, location, or employer can require an amended H-1B petition. If your core QA Auditor responsibilities shift significantly, USCIS expects your employer to file an amended I-129 before the change takes effect. Failing to do so can create a period of unauthorized employment, so you should flag any substantial role changes to your employer's immigration counsel promptly.