Lead Quality Engineer Visa Sponsorship Jobs in Illinois
Lead quality engineer roles in Illinois draw consistent visa sponsorship activity, with major employers across Chicago's tech corridor, suburban manufacturing hubs like Schaumburg and Naperville, and global firms such as Motorola Solutions, Abbott, and Caterpillar's Illinois operations filing regularly for engineering talent. Illinois's mix of software, medical device, and industrial manufacturing sectors keeps demand steady year-round.
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About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
The Lead Digital Health Quality Engineer will serve as representative on cross-functional SaMD and Digital Health Software product development teams, driving design controls, DHF management, software validation, and risk management (ISO 14971) throughout the software life cycle. This role will Author, review, and approve QMS and project documentation — including risk management files — to ensure products are developed, tested, and released in compliance with applicable SDLC procedure and/or medical device regulations. This role will lead quality process improvement initiatives, support regulatory characterization and audit, and contribute to cybersecurity quality activities, applying IEC 62304 and strong technical writing and cross-functional collaboration skills.
Responsibilities:
- Responsible for compliance with applicable Corporate and Divisional policies, procedures, and global regulations governing Digital Health applications and SaMD, including AbbVie's software lifecycle requirements, using standard methodologies, processes, and tools.
- Perform design control and risk management activities (including cybersecurity risk management) per AbbVie's Quality System, partnering with technical teams to ensure design control documentation (risk management, traceability/linkages) and design change control requirements are met.
- Experience with Computer Software Assurance (CSA) and GAMP5 principles for software validation and lifecycle activities.
- Write/review processes, procedures, and related documents for the development of SaMD and Digital Health products in compliance with global regulations.
- Support the creation of regulatory submission documentation.
- Support Corrective and Preventive Action (CAPA) activities related to SaMD and Digital Health quality issues, including root cause analysis, effectiveness checks, and closure.
- Assist in the preparation of, and support, regulatory agency and internal audits.
- Lead and actively participate in continuous improvement initiatives — including within the Design History File and Risk Management — anticipating and resolving quality issues, taking preventative action, and tracking improvements to closure.
- Serve as a subject matter expert on SaMD/Digital Health quality and regulatory requirements across cross-functional teams.
- Communicate SaMD/Digital Health project and quality status through timely, accurate reports to project teams, and management, and recommend actions to resolve emerging issues.
- Initiate assignments independently, exercising considerable latitude in determining objectives and approach.
Qualifications
Required:
- Bachelor’s Degree with 6 years of experience; or Master’s Degree with 5 years of experience; or PhD with 0 years of experience.
- Experience in coordination and planning of complex activities and ability to identify and resolve complex problems through effective use of technical and interpersonal skills.
- Experience in a quality systems environment, or equivalent combination of work experience; excellent analytical, judgment, and consultative capabilities; and strong communication skills with the ability to work effectively with cross-functional teams.
- Exercises considerable latitude in determining the objectives of and approach of assigned work.
- Strong understanding of regulations and standards affecting software medical devices such as IEC 62304, ISO 14971, 21 CFR 820.30 and EU MDR.
- Experience with creation and maintenance of QMS documents for development of medical devices.
Preferred:
- Familiarity with medical device cybersecurity; AI/ML; Connected devices; Digital Health emerging Technologies; AI/ML awareness is a plus.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
The Lead Digital Health Quality Engineer will serve as representative on cross-functional SaMD and Digital Health Software product development teams, driving design controls, DHF management, software validation, and risk management (ISO 14971) throughout the software life cycle. This role will Author, review, and approve QMS and project documentation — including risk management files — to ensure products are developed, tested, and released in compliance with applicable SDLC procedure and/or medical device regulations. This role will lead quality process improvement initiatives, support regulatory characterization and audit, and contribute to cybersecurity quality activities, applying IEC 62304 and strong technical writing and cross-functional collaboration skills.
Responsibilities:
- Responsible for compliance with applicable Corporate and Divisional policies, procedures, and global regulations governing Digital Health applications and SaMD, including AbbVie's software lifecycle requirements, using standard methodologies, processes, and tools.
- Perform design control and risk management activities (including cybersecurity risk management) per AbbVie's Quality System, partnering with technical teams to ensure design control documentation (risk management, traceability/linkages) and design change control requirements are met.
- Experience with Computer Software Assurance (CSA) and GAMP5 principles for software validation and lifecycle activities.
- Write/review processes, procedures, and related documents for the development of SaMD and Digital Health products in compliance with global regulations.
- Support the creation of regulatory submission documentation.
- Support Corrective and Preventive Action (CAPA) activities related to SaMD and Digital Health quality issues, including root cause analysis, effectiveness checks, and closure.
- Assist in the preparation of, and support, regulatory agency and internal audits.
- Lead and actively participate in continuous improvement initiatives — including within the Design History File and Risk Management — anticipating and resolving quality issues, taking preventative action, and tracking improvements to closure.
- Serve as a subject matter expert on SaMD/Digital Health quality and regulatory requirements across cross-functional teams.
- Communicate SaMD/Digital Health project and quality status through timely, accurate reports to project teams, and management, and recommend actions to resolve emerging issues.
- Initiate assignments independently, exercising considerable latitude in determining objectives and approach.
Qualifications
Required:
- Bachelor’s Degree with 6 years of experience; or Master’s Degree with 5 years of experience; or PhD with 0 years of experience.
- Experience in coordination and planning of complex activities and ability to identify and resolve complex problems through effective use of technical and interpersonal skills.
- Experience in a quality systems environment, or equivalent combination of work experience; excellent analytical, judgment, and consultative capabilities; and strong communication skills with the ability to work effectively with cross-functional teams.
- Exercises considerable latitude in determining the objectives of and approach of assigned work.
- Strong understanding of regulations and standards affecting software medical devices such as IEC 62304, ISO 14971, 21 CFR 820.30 and EU MDR.
- Experience with creation and maintenance of QMS documents for development of medical devices.
Preferred:
- Familiarity with medical device cybersecurity; AI/ML; Connected devices; Digital Health emerging Technologies; AI/ML awareness is a plus.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Lead Quality Engineer Job Roles in Illinois
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Search Lead Quality Engineer Jobs in IllinoisLead Quality Engineer Jobs in Illinois: Frequently Asked Questions
Which companies in Illinois sponsor visas for lead quality engineers?
Illinois employers with active engineering sponsorship histories include Motorola Solutions, Abbott Laboratories, Caterpillar, Baxter International, and Boeing's Chicago-area operations. Smaller medical device and industrial automation firms in the Chicago metro and collar counties also file regularly. Because sponsorship patterns shift year to year, checking verified LCA filing records gives you a more accurate picture than company reputation alone.
Which visa types realistically apply to lead quality engineer roles in Illinois?
H-1B visa is the primary path: lead quality engineering qualifies as a specialty occupation requiring a directly related bachelor's degree, so employers file an LCA and I-129 petition with USCIS. H-1B1 visa applies to Chilean and Singaporean nationals. E-3 visa covers Australian citizens. TN visa is available to Canadian and Mexican engineers under USMCA. EB-2 and EB-3 green cards are viable long-term routes, typically using PERM labor certification.
How to find lead quality engineer visa sponsorship jobs in Illinois?
Migrate Mate lists Illinois employers with verified sponsorship filing histories for engineering roles, including lead quality engineer positions, so you can focus on companies already comfortable with the process. Searching by Illinois on Migrate Mate surfaces active sponsors across Chicago, Schaumburg, Naperville, and other hiring centers, saving time you'd otherwise spend vetting employers who have never sponsored a visa.
Which Illinois cities have the most lead quality engineer sponsorship opportunities?
Chicago anchors the state's sponsorship activity, particularly for tech and software-driven quality engineering roles. Schaumburg and Hoffman Estates host significant Motorola Solutions and IT services operations. Naperville and Downers Grove attract medical device and manufacturing employers. North Chicago and Lake County see consistent demand from Abbott and Baxter, making the entire I-88 and I-294 corridor productive territory for sponsored roles.
Are there Illinois-specific factors that affect visa sponsorship for lead quality engineers?
Illinois's concentration of FDA-regulated medical device manufacturers and aerospace suppliers creates steady demand for quality engineering leadership, which tends to support sponsorship willingness. The state's large research university pipeline, including University of Illinois and Northwestern alumni networks, means many Illinois employers already have established relationships with international engineering candidates and existing processes for H-1B and green card filings.
What is the prevailing wage for sponsored lead quality engineer jobs in Illinois?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.