H-1B Visa Director of Quality Jobs
Director of Quality jobs at H-1B visa sponsoring employers sit firmly in specialty occupation territory, requiring at least a bachelor's degree in engineering, quality management, or a closely related field. Employers file a Labor Condition Application with DOL and an I-129 petition with USCIS, covering an initial three-year status period with extensions available.
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General Summary:
The Senior Director, Device Quality provides strategic Quality leadership and oversight for Vertex device and combination product operations across development, manufacturing, testing, clinical, commercial, and post-market activities.
The role is accountable for risk-based operational Quality oversight of internal activities and external partners, including CDMOs, testing laboratories, and critical suppliers. The role ensures compliance with ISO 13485, 21 CFR Part 820, ISO 14971, and applicable global device and combination product requirements.
The Senior Director serves as the Management Representative for the Device QMS, providing leadership for QMS effectiveness, regulatory compliance, management review, inspection readiness, and continual improvement. The role partners with senior Quality and business leaders on enterprise Quality initiatives.
Key Duties and Responsibilities:
-
Define and execute the Device Operational QA strategy aligned with business, portfolio, and product priorities.
-
Provide Quality oversight of CDMOs, suppliers, testing laboratories, and other external partners, including quality agreements, audits, performance, and risk management.
-
Provide Quality oversight of internal design control, design transfer, manufacturing, testing, and product realization activities.
-
Serve as Management Representative for the Device QMS, ensuring QMS effectiveness, management review, compliance, and continual improvement.
-
Ensure compliance with ISO 13485, 21 CFR Part 820, ISO 14971, and applicable global regulatory requirements.
-
Provide strategic oversight of deviations, investigations, CAPA, change control, complaints, supplier quality, audits, and inspection readiness.
-
Establish and monitor Quality metrics, risks, trends, and performance, driving timely escalation and resolution of significant issues.
-
Provide Quality leadership for regulatory inspections, notified body audits, product milestones, and launch readiness.
-
Partner with senior leaders on enterprise-wide Quality initiatives that improve compliance, operational effectiveness, and business performance.
-
Build organizational capability through talent development, coaching, and strong cross-functional leadership.
Knowledge and Skills:
-
Broad expertise in Device and Combination Product Quality Assurance, QMS, and operational Quality oversight.
-
Strong knowledge of ISO 13485, 21 CFR Part 820, ISO 14971, and applicable global regulatory requirements.
-
Demonstrated experience with CDMO/external partner oversight, supplier Quality, testing, audits, and inspection readiness.
-
Strong understanding of design controls, design transfer, risk management, manufacturing controls, supplier controls, and product realization.
-
Proven experience with CAPA, investigations, deviations, change control, complaints, and quality risk management.
-
Demonstrated capability to serve as Management Representative, including QMS performance, management review, compliance oversight, and risk escalation.
-
Strong strategic thinking, business acumen, risk-based decision-making, and problem-solving skills.
-
Ability to influence senior leaders and drive outcomes in a complex, matrixed organization.
-
Demonstrated leadership in cross-functional strategic initiatives.
-
Strong people leadership skills with demonstrated ability to develop talent, build organizational capability, and foster Quality ownership.
Education and Experience:
Bachelors degree in a scientific, allied health, or operations research field. Typically requires 15 years of relevant work experience and 5 years of supervisory/management experience or the equivalent combination of education and experience.
LI-Hybrid
At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.
Pay Range:
$213,600 - $320,400
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
-
Hybrid: work remotely up to two days per week; or select
-
On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
LI-Hybrid
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
Job Description
General Summary:
The Senior Director, Device Quality provides strategic Quality leadership and oversight for Vertex device and combination product operations across development, manufacturing, testing, clinical, commercial, and post-market activities.
The role is accountable for risk-based operational Quality oversight of internal activities and external partners, including CDMOs, testing laboratories, and critical suppliers. The role ensures compliance with ISO 13485, 21 CFR Part 820, ISO 14971, and applicable global device and combination product requirements.
The Senior Director serves as the Management Representative for the Device QMS, providing leadership for QMS effectiveness, regulatory compliance, management review, inspection readiness, and continual improvement. The role partners with senior Quality and business leaders on enterprise Quality initiatives.
Key Duties and Responsibilities:
-
Define and execute the Device Operational QA strategy aligned with business, portfolio, and product priorities.
-
Provide Quality oversight of CDMOs, suppliers, testing laboratories, and other external partners, including quality agreements, audits, performance, and risk management.
-
Provide Quality oversight of internal design control, design transfer, manufacturing, testing, and product realization activities.
-
Serve as Management Representative for the Device QMS, ensuring QMS effectiveness, management review, compliance, and continual improvement.
-
Ensure compliance with ISO 13485, 21 CFR Part 820, ISO 14971, and applicable global regulatory requirements.
-
Provide strategic oversight of deviations, investigations, CAPA, change control, complaints, supplier quality, audits, and inspection readiness.
-
Establish and monitor Quality metrics, risks, trends, and performance, driving timely escalation and resolution of significant issues.
-
Provide Quality leadership for regulatory inspections, notified body audits, product milestones, and launch readiness.
-
Partner with senior leaders on enterprise-wide Quality initiatives that improve compliance, operational effectiveness, and business performance.
-
Build organizational capability through talent development, coaching, and strong cross-functional leadership.
Knowledge and Skills:
-
Broad expertise in Device and Combination Product Quality Assurance, QMS, and operational Quality oversight.
-
Strong knowledge of ISO 13485, 21 CFR Part 820, ISO 14971, and applicable global regulatory requirements.
-
Demonstrated experience with CDMO/external partner oversight, supplier Quality, testing, audits, and inspection readiness.
-
Strong understanding of design controls, design transfer, risk management, manufacturing controls, supplier controls, and product realization.
-
Proven experience with CAPA, investigations, deviations, change control, complaints, and quality risk management.
-
Demonstrated capability to serve as Management Representative, including QMS performance, management review, compliance oversight, and risk escalation.
-
Strong strategic thinking, business acumen, risk-based decision-making, and problem-solving skills.
-
Ability to influence senior leaders and drive outcomes in a complex, matrixed organization.
-
Demonstrated leadership in cross-functional strategic initiatives.
-
Strong people leadership skills with demonstrated ability to develop talent, build organizational capability, and foster Quality ownership.
Education and Experience:
Bachelors degree in a scientific, allied health, or operations research field. Typically requires 15 years of relevant work experience and 5 years of supervisory/management experience or the equivalent combination of education and experience.
LI-Hybrid
At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.
Pay Range:
$213,600 - $320,400
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
-
Hybrid: work remotely up to two days per week; or select
-
On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
LI-Hybrid
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
See all 192+ H-1B Visa Director of Quality Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Director of Quality Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Director of Quality
Align your credentials to SOC codes
Director of Quality roles map to SOC codes like 11-1021 or 17-2112 depending on industry. Pull the O*NET profile for your target code and confirm your degree field and job duties match before applying, since USCIS scrutinizes specialty occupation fit at this level.
Verify prevailing wage before negotiating
Run your target city and SOC code through the OFLC Wage Search before entering salary discussions. Your employer's LCA must certify a wage at or above the prevailing level, so knowing the threshold prevents late-stage offer collapses when DOL certification is filed.
Target manufacturers with multi-site LCA history
Quality directors often oversee multiple plants, but each worksite requires its own certified LCA. Focus on employers in regulated industries like aerospace, medical devices, and automotive, where legal teams already manage multi-site H-1B compliance and won't be surprised by the requirement.
Find sponsors through Migrate Mate's verified employer database
Filter Director of Quality roles on Migrate Mate to surface employers with verified H-1B LCA filing history. This cuts out companies that list quality leadership roles but lack any track record of sponsoring international hires at the director level.
Request premium processing during offer negotiation
USCIS premium processing cuts I-129 adjudication to 15 business days. For director-level hires, employers often absorb this cost voluntarily, but confirm it in writing during the offer stage since delays can affect start dates tied to project launches or fiscal quarters.
Document quality system credentials with USCIS in mind
Certifications like ASQ CQE, CQM, or ISO lead auditor credentials strengthen the specialty occupation argument in an I-129 petition. Compile official transcripts, degree equivalency evaluations, and certification records into a single package your employer's attorney can reference quickly.
H-1B Visa Director of Quality: Frequently Asked Questions
Does a Director of Quality role qualify as a specialty occupation for H-1B purposes?
Yes. Director of Quality positions typically qualify because they require at least a bachelor's degree in engineering, quality management, industrial engineering, or a closely related field. USCIS evaluates the specific job duties and degree requirement listed in the offer letter, so employers must write the role description to reflect degree-level responsibilities rather than purely supervisory or administrative functions.
How do I find employers who actively sponsor H-1B visas for quality leadership roles?
Search Migrate Mate to browse Director of Quality openings at companies with verified H-1B LCA filing history. Employers in regulated manufacturing sectors, medical devices, aerospace, and pharmaceuticals file LCAs most consistently for quality roles because regulatory frameworks like FDA 21 CFR Part 820 and AS9100 require degree-qualified leadership, making sponsorship a standard part of their hiring process.
What happens to my H-1B status if the company restructures or my reporting line changes?
A material change in job duties, worksite, or salary can require an amended I-129 petition before the change takes effect. If your role shifts from directing quality systems to primarily managing headcount without technical oversight, USCIS may question whether specialty occupation criteria still apply. Confirm with your employer's immigration attorney before any formal role modification.
Can my employer use one LCA if I travel between facilities for quality audits?
Short-term worksite visits generally fall under H-1B short-term placement rules, but a secondary location where you work more than a few days requires its own certified LCA. Quality directors conducting extended on-site audits at client or sister facilities should confirm their employer has filed the correct LCA coverage for each location before traveling.
How long does the H-1B sponsorship process take for a Director of Quality hire?
DOL typically certifies an LCA within seven business days. USCIS then adjudicates the I-129 petition within three to five months under standard processing, or in 15 business days under premium processing. Total timeline from offer acceptance to approved status commonly runs four to six months, though employers in regulated industries often start the process well before the target start date.