Principal Quality Engineer Visa Sponsorship Jobs in Indiana
Principal quality engineer visa sponsorship jobs in Indiana draw from the state's advanced manufacturing base, with major employers like Eli Lilly, Cummins, and Rolls-Royce filing sponsorship petitions across Indianapolis, Columbus, and Fort Wayne. Indiana's engineering-driven economy supports strong demand for senior quality leadership across medical devices, automotive, and defense sectors.
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Provide quality support and assurance for ICU Medical product development. The Quality Engineer will be responsible for development procedures and deliverables, ensuring their compliance with ICU Medical quality system requirements and applicable regulations and standards (such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards). The Quality Engineer will provide quality assurance support for product realization/manufacturing teams for the system (includes aspects of electro-mechanical, software and consumable components) product lines. This individual will be the Quality Core Team Member for ensuring products are developed/manufactured utilizing appropriate processes to design the highest level of quality into products as they are developed.
Essential Duties & Responsibilities
- Ensure the safety of products developed by managing the product life cycle activities to meet the quality system requirements.
- Ensure compliance, alignment and consistency with ICU Medical’s quality system and development practices.
- Effectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc. to assure product quality.
- Prepare, support and ensure the readiness for any potential internal and/or external audits and inspections.
- Perform periodic audits of projects against SOP’s and process.
- Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, code review, and unit test inspections.
- Review, approve and participate in qualification of acquired software and software tools.
- Perform and support product risk analysis and management.
- Utilize a wide variety of data sources including product review, global complaints, manufacturing quality data, etc.
- Monitor product data to identify statistically significant trends and risks.
- Support on-market issue investigations, risk assessments and associated CAPA activities.
- Review and approve resolution of on-market product issues.
- Support regulatory submissions and responses to regulatory inquiries.
- Work special projects as assigned.
Knowledge & Skills
- Expert quality compliance, audit, and investigation skills.
- In depth deep and broad knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc.).
- Strong knowledge of medical device standards, including but not limited to:
- ISO 13485
- ISO 14971
- IEC 60601
- IEC 62304
- In depth experience with and knowledge of FDA, MDR, and other key medical device regulations.
- Well-developed ability to take a systems approach and to understand the interaction between components (i.e. hardware, software, consumables).
- Proven ability to work closely with engineering teams and members of a cross functional team.
- New product development experience is strongly preferred.
Minimum Qualifications, Education & Experience
- Must be at least 18 years of age.
- Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical, Software) or related field from an accredited college or university is required.
- Minimum of 7+ years of experience in quality engineering, product design or product engineering in the medical device industry.
- ASQ CQE or CSQE required or the ability to obtain within one year.
Work Environment
- This is largely a sedentary role.
- This job operates in a professional office environment and routinely uses standard office equipment.
- Typically requires travel 5% to 10% of the time.
Position Summary
Provide quality support and assurance for ICU Medical product development. The Quality Engineer will be responsible for development procedures and deliverables, ensuring their compliance with ICU Medical quality system requirements and applicable regulations and standards (such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards). The Quality Engineer will provide quality assurance support for product realization/manufacturing teams for the system (includes aspects of electro-mechanical, software and consumable components) product lines. This individual will be the Quality Core Team Member for ensuring products are developed/manufactured utilizing appropriate processes to design the highest level of quality into products as they are developed.
Essential Duties & Responsibilities
- Ensure the safety of products developed by managing the product life cycle activities to meet the quality system requirements.
- Ensure compliance, alignment and consistency with ICU Medical’s quality system and development practices.
- Effectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc. to assure product quality.
- Prepare, support and ensure the readiness for any potential internal and/or external audits and inspections.
- Perform periodic audits of projects against SOP’s and process.
- Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, code review, and unit test inspections.
- Review, approve and participate in qualification of acquired software and software tools.
- Perform and support product risk analysis and management.
- Utilize a wide variety of data sources including product review, global complaints, manufacturing quality data, etc.
- Monitor product data to identify statistically significant trends and risks.
- Support on-market issue investigations, risk assessments and associated CAPA activities.
- Review and approve resolution of on-market product issues.
- Support regulatory submissions and responses to regulatory inquiries.
- Work special projects as assigned.
Knowledge & Skills
- Expert quality compliance, audit, and investigation skills.
- In depth deep and broad knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc.).
- Strong knowledge of medical device standards, including but not limited to:
- ISO 13485
- ISO 14971
- IEC 60601
- IEC 62304
- In depth experience with and knowledge of FDA, MDR, and other key medical device regulations.
- Well-developed ability to take a systems approach and to understand the interaction between components (i.e. hardware, software, consumables).
- Proven ability to work closely with engineering teams and members of a cross functional team.
- New product development experience is strongly preferred.
Minimum Qualifications, Education & Experience
- Must be at least 18 years of age.
- Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical, Software) or related field from an accredited college or university is required.
- Minimum of 7+ years of experience in quality engineering, product design or product engineering in the medical device industry.
- ASQ CQE or CSQE required or the ability to obtain within one year.
Work Environment
- This is largely a sedentary role.
- This job operates in a professional office environment and routinely uses standard office equipment.
- Typically requires travel 5% to 10% of the time.
Principal Quality Engineer Job Roles in Indiana
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Search Principal Quality Engineer Jobs in IndianaPrincipal Quality Engineer Jobs in Indiana: Frequently Asked Questions
Which companies in Indiana sponsor visas for principal quality engineers?
Indiana employers with active engineering sponsorship histories include Eli Lilly and Company in Indianapolis, Cummins Inc. in Columbus, Rolls-Royce in Indianapolis, Subaru of Indiana Automotive in Lafayette, and Cook Medical in Bloomington. These companies regularly file for senior engineering roles through H-1B visa and other work visa categories, particularly in quality systems, process validation, and regulatory compliance functions.
What visa types realistically apply to principal quality engineer roles in Indiana?
Principal quality engineer roles typically qualify as specialty occupations requiring a bachelor's degree in engineering or a closely related field, making H-1B the most common path. Canadian and Mexican nationals may qualify under TN visa status as engineers under the USMCA profession list. F-1 graduates with STEM-designated degrees may bridge on OPT or STEM OPT while pursuing H-1B sponsorship. EB-2 and EB-3 employment-based green cards are also available through PERM labor certification for permanent roles.
Which Indiana cities have the most principal quality engineer sponsorship jobs?
Indianapolis leads the state, anchored by life sciences, defense, and advanced manufacturing employers concentrated in the metro area. Columbus is a secondary hub due to Cummins' global headquarters and its supplier network. Lafayette and West Lafayette benefit from Subaru's manufacturing presence and proximity to Purdue University's engineering talent pipeline. Fort Wayne supports quality engineering roles tied to its automotive components and industrial manufacturing cluster.
How to find principal quality engineer visa sponsorship jobs in Indiana?
Migrate Mate lists Indiana employers with verified visa sponsorship filing histories for engineering roles, letting you search specifically for principal quality engineer positions at companies already committed to sponsorship in the state. Because Indiana's sponsorship activity is concentrated among a relatively small number of large manufacturers and life sciences firms, using a platform that surfaces verified employer filing data saves significant research time compared to general job searches.
Are there any Indiana-specific considerations for principal quality engineers seeking visa sponsorship?
Indiana's engineering hiring is heavily tied to its medical device and pharmaceutical manufacturing sectors, particularly around Indianapolis, which means quality engineers with FDA regulatory experience, ISO 13485, or cGMP backgrounds are especially competitive for sponsorship. Purdue University's engineering programs also create a steady local pipeline, so employers in the Lafayette corridor are accustomed to sponsoring international engineering talent at various career levels, including senior and principal grades.
What is the prevailing wage for sponsored principal quality engineer jobs in Indiana?
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.