Quality Assurance Engineer Visa Sponsorship Jobs in Minnesota
Minnesota's quality assurance engineer job market is anchored by medical device giants like Medtronic, Boston Scientific, and Abbott, alongside manufacturing firms and software companies in the Twin Cities metro. Minneapolis, St. Paul, and Plymouth are the main hiring hubs. Many employers here have established visa sponsorship programs for QA engineering talent.
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Get Access To All JobsSUMMARY
This role is responsible for operational quality input and deliverables for manufacturing programs throughout the product lifecycle. Quality Assurance Engineers will also support development activities as they prepare to launch into commercial manufacturing, such as manufacturing readiness, audits, and clinical builds to ensure a smooth transition and continuously accurate and compliant Design History File. All engineering functions are responsible for compliance with the Quality System and relevant regulations and standards, continuous improvement, and as needed, professional interaction with Nextern Customers.
Duties And Responsibilities
Project core team member accountable for operations deliverables including, but not limited to:
- Document Control & Audit Readiness: Author and approve SOPs, work instructions, and forms. Support internal audits and maintain inspection readiness across the quality system.
- Data & Continuous Improvement: Compile and trend quality metrics to identify systemic issues. Present actionable insights to leadership and drive implementation of corrective and preventive actions.
- Incoming Inspection & Supplier Quality: Oversee incoming inspection per approved sampling plans. Disposition nonconforming materials and coordinate supplier corrective actions to address recurring quality issues.
- Equipment & Process Oversight: Provide quality oversight for IQ/OQ/PQ qualification activities. Review and approve protocols, reports, and change orders. Evaluate regulatory impact of equipment changes prior to implementation.
- NC & CAPA Leadership: Manage nonconformances and CAPAs from initiation through effectiveness verification. Lead root cause analysis using structured methods (5-Why, fishbone). Trend data and report findings at management review.
- Operations Quality Support:
- Act as the quality point of contact for production.
- Review batch records and travelers for GMP compliance.
- Support line clearances, first-article inspections, and process change reviews.
- Draft, collaborate, and approve product and engineering work orders.
- Create and maintain up-to-date product Design History Files (DHF).
- Advise project teams and lead by example in best-practices for Quality and Regulatory Compliance.
- Own, review, and approve changes ensuring impacts and resulting action/implementation (or lack thereof) are properly documented and executed.
- Receive, investigate, and document product complaints, interacting with customers as applicable.
- Support audits as Subject Matter Expert (SME) for QMS processes and product DHFs.
- Drive Product Lifecycle Management (PLM) architecture and changes, as needed.
Supervisory Responsibilities
This job has no direct supervisory responsibility.
Requirements
QUALIFICATIONS
- Bachelor's Degree (BS) in life science discipline or equivalent combination of education and experience.
- 5+ years of experience in medical device development, or 3+ years of experience in a Design Assurance or Quality Engineering role
- Experience working in quality systems as defined in 21 CFR 820 and ISO 13485.
- Development project team member on complex medical device development programs, including systems
- Understanding of ISO 14971 and application of risk management to product development and processes.
- Demonstrated technical expertise and leadership in quality.
- High attention to detail, organization, and accuracy.
- Instinctual capability for creative thinking and proposing novel solutions
- Strong ability to communicate (written and verbally) within and across disciplines and organization structures.
- Demonstrated use of quality tools and methodologies (e.g. nonconformance, CAPAs, root cause analysis, etc.).
- Familiarity with statistical software, such as Minitab, preferred.
- Experience with Product Lifecycle Management (PLM) software (e.g Windchill, Agile, Propel)
- Intermediate to advanced proficiency with MS Office Suite (Word, Excel, PowerPoint, Project, Outlook).
Benefits
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan with Company Match
- Paid Time Off, Personal Days, AND Birthday Holiday!
- Lifetime Membership Subsidy and Wellness Resources
- Life Insurance (Basic, Voluntary & AD&D)
- MN Paid Leave
- Short-Term & Long-Term Disability
- Taco Thursdays!!!
Nextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
SUMMARY
This role is responsible for operational quality input and deliverables for manufacturing programs throughout the product lifecycle. Quality Assurance Engineers will also support development activities as they prepare to launch into commercial manufacturing, such as manufacturing readiness, audits, and clinical builds to ensure a smooth transition and continuously accurate and compliant Design History File. All engineering functions are responsible for compliance with the Quality System and relevant regulations and standards, continuous improvement, and as needed, professional interaction with Nextern Customers.
Duties And Responsibilities
Project core team member accountable for operations deliverables including, but not limited to:
- Document Control & Audit Readiness: Author and approve SOPs, work instructions, and forms. Support internal audits and maintain inspection readiness across the quality system.
- Data & Continuous Improvement: Compile and trend quality metrics to identify systemic issues. Present actionable insights to leadership and drive implementation of corrective and preventive actions.
- Incoming Inspection & Supplier Quality: Oversee incoming inspection per approved sampling plans. Disposition nonconforming materials and coordinate supplier corrective actions to address recurring quality issues.
- Equipment & Process Oversight: Provide quality oversight for IQ/OQ/PQ qualification activities. Review and approve protocols, reports, and change orders. Evaluate regulatory impact of equipment changes prior to implementation.
- NC & CAPA Leadership: Manage nonconformances and CAPAs from initiation through effectiveness verification. Lead root cause analysis using structured methods (5-Why, fishbone). Trend data and report findings at management review.
- Operations Quality Support:
- Act as the quality point of contact for production.
- Review batch records and travelers for GMP compliance.
- Support line clearances, first-article inspections, and process change reviews.
- Draft, collaborate, and approve product and engineering work orders.
- Create and maintain up-to-date product Design History Files (DHF).
- Advise project teams and lead by example in best-practices for Quality and Regulatory Compliance.
- Own, review, and approve changes ensuring impacts and resulting action/implementation (or lack thereof) are properly documented and executed.
- Receive, investigate, and document product complaints, interacting with customers as applicable.
- Support audits as Subject Matter Expert (SME) for QMS processes and product DHFs.
- Drive Product Lifecycle Management (PLM) architecture and changes, as needed.
Supervisory Responsibilities
This job has no direct supervisory responsibility.
Requirements
QUALIFICATIONS
- Bachelor's Degree (BS) in life science discipline or equivalent combination of education and experience.
- 5+ years of experience in medical device development, or 3+ years of experience in a Design Assurance or Quality Engineering role
- Experience working in quality systems as defined in 21 CFR 820 and ISO 13485.
- Development project team member on complex medical device development programs, including systems
- Understanding of ISO 14971 and application of risk management to product development and processes.
- Demonstrated technical expertise and leadership in quality.
- High attention to detail, organization, and accuracy.
- Instinctual capability for creative thinking and proposing novel solutions
- Strong ability to communicate (written and verbally) within and across disciplines and organization structures.
- Demonstrated use of quality tools and methodologies (e.g. nonconformance, CAPAs, root cause analysis, etc.).
- Familiarity with statistical software, such as Minitab, preferred.
- Experience with Product Lifecycle Management (PLM) software (e.g Windchill, Agile, Propel)
- Intermediate to advanced proficiency with MS Office Suite (Word, Excel, PowerPoint, Project, Outlook).
Benefits
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan with Company Match
- Paid Time Off, Personal Days, AND Birthday Holiday!
- Lifetime Membership Subsidy and Wellness Resources
- Life Insurance (Basic, Voluntary & AD&D)
- MN Paid Leave
- Short-Term & Long-Term Disability
- Taco Thursdays!!!
Nextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Quality Assurance Engineer Job Roles in Minnesota
See all 81+ Quality Assurance Engineer Jobs in Minnesota
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Search Quality Assurance Engineer Jobs in MinnesotaQuality Assurance Engineer Jobs in Minnesota: Frequently Asked Questions
Which companies sponsor visas for quality assurance engineers in Minnesota?
Medtronic, Boston Scientific, and Abbott are among the largest visa-sponsoring employers for quality assurance engineers in Minnesota, driven by the state's concentration of medical device manufacturing. Large technology and manufacturing firms such as Ecolab, 3M, and Cargill also have documented H-1B visa sponsorship histories. Sponsorship availability varies by role, team, and hiring cycle, so confirming directly with the employer is always necessary.
Which visa types are most common for quality assurance engineer roles in Minnesota?
The H-1B visa is the most common pathway for quality assurance engineers in Minnesota, as the role typically qualifies as a specialty occupation requiring at least a bachelor's degree in engineering, computer science, or a related field. Some candidates, particularly those from Australia, may be eligible for the E-3 visa. Canadian and Mexican nationals may qualify under the TN visa category for engineering roles listed in the USMCA schedule.
Which cities in Minnesota have the most quality assurance engineer sponsorship jobs?
The Twin Cities metro area, specifically Minneapolis, St. Paul, and inner-ring suburbs like Plymouth, Fridley, and Arden Hills, accounts for the large majority of quality assurance engineer sponsorship jobs in Minnesota. Plymouth is particularly notable as the home base for several Medtronic and Boston Scientific facilities. Rochester also has engineering employer presence tied to IBM and health technology companies in that corridor.
How to find quality assurance engineer visa sponsorship jobs in Minnesota?
Migrate Mate is built specifically for international candidates seeking visa sponsorship roles, and you can filter directly for quality assurance engineer positions in Minnesota. Because QA engineering in Minnesota is heavily tied to the medical device and manufacturing sectors, filtering by industry can surface employers with stronger sponsorship track records. Migrate Mate surfaces roles where employers have indicated sponsorship openness, which saves significant time compared to screening general job listings manually.
Are there state-specific factors that affect quality assurance engineer sponsorship hiring in Minnesota?
Minnesota's medical device industry concentration means many QA engineer roles fall under FDA-regulated environments, which often require domain-specific experience in quality systems such as ISO 13485 or 21 CFR Part 820. Employers in this sector tend to hire for precision and compliance knowledge, not just general QA skills. The University of Minnesota and Minnesota State system also supply a pipeline of engineering graduates, meaning sponsored candidates generally need differentiated technical backgrounds to remain competitive.
What is the prevailing wage for sponsored quality assurance engineer jobs in Minnesota?
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.