Quality Engineer Jobs for OPT Students
Quality Engineer jobs are a strong fit for F-1 OPT students with degrees in mechanical, industrial, or manufacturing engineering. Most roles qualify as STEM OPT extensions, giving you up to 36 months of work authorization. Employers in automotive, aerospace, and medical devices regularly hire OPT candidates for inspection, process control, and compliance work.
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INTRODUCTION
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JOB DETAILS
This Jobot Job is hosted by: Amanda Preston
Are you a fit? Easy Apply now by clicking the "Easy Apply" button and sending us your resume.
Salary: $105,000 - $130,000 per year
A bit about us:
We are a global pharmaceutical organization dedicated to developing and delivering innovative therapies that improve patient outcomes worldwide. With a strong presence across both drug and device development, we operate at the forefront of combination products, integrating science, technology, and patient-centric design. Our teams are committed to advancing quality, compliance, and innovation across the product lifecycle, ensuring that every product meets the highest standards of safety, efficacy, and regulatory excellence.
Why join us?
This is a unique opportunity to work within a highly regulated and innovation-driven environment at the intersection of pharmaceuticals and medical devices. You will play a critical role in supporting combination product development and commercial programs that directly impact patients’ lives. You will be part of a collaborative, cross-functional team where your expertise in quality and compliance will help shape product development, influence regulatory strategy, and drive continuous improvement across complex systems.
POSITION OVERVIEW
We are seeking a Quality Engineer with experience in pharmaceutical, medical device, or combination product environments to support quality systems, design controls, and risk management activities. This role will partner closely with R&D, manufacturing, regulatory, and external partners to ensure compliance and quality throughout the product lifecycle.
KEY RESPONSIBILITIES
- Support design control and risk management activities for combination product development programs
- Ensure compliance with applicable quality and regulatory standards, including FDA and global requirements
- Partner with cross-functional teams to support product development, validation, and commercialization efforts
- Participate in risk assessments, including FMEA and hazard analyses, and support mitigation strategies
- Support design verification and validation activities, including human factors and usability considerations
- Contribute to regulatory submissions by supporting quality-related documentation and data
- Investigate quality issues and support root cause analysis and CAPA implementation
- Collaborate with external partners, including design firms and manufacturers, to ensure quality system alignment
- Support internal and external audits and inspections
- Identify and drive continuous improvement initiatives across quality systems and processes
QUALIFICATIONS
- Bachelor’s, Master’s, or PhD in Engineering or a related scientific discipline (e.g., Biomedical, Mechanical, Chemical, Materials, or Life Sciences)
- 3+ years of experience in pharmaceutical, medical device, or combination product environments
- Strong understanding of design controls and risk management principles
- Working knowledge of applicable standards and regulations, including ISO 13485, ISO 14971, 21 CFR 820, 21 CFR Part 4, and EU MDR
- Familiarity with Human Factors / Usability Engineering is preferred
- Understanding of Good Manufacturing Practices (GMP)
- Experience with validation, verification, and quality system processes
SKILLS AND COMPETENCIES
- Strong analytical and problem-solving skills with attention to detail
- Ability to manage multiple priorities in a fast-paced, regulated environment
- Effective collaboration across cross-functional and global teams
- Strong communication skills, both written and verbal
- Ability to work independently while maintaining alignment with broader project goals
- Proficiency in standard business tools and data analysis
Interested in hearing more? Easy Apply now by clicking the "Easy Apply" button.
Want to learn more about this role and Jobot?
Click our Jobot logo and follow our LinkedIn page!

INTRODUCTION
Want to learn more about this role and Jobot? Click our Jobot logo and follow our LinkedIn page!
JOB DETAILS
This Jobot Job is hosted by: Amanda Preston
Are you a fit? Easy Apply now by clicking the "Easy Apply" button and sending us your resume.
Salary: $105,000 - $130,000 per year
A bit about us:
We are a global pharmaceutical organization dedicated to developing and delivering innovative therapies that improve patient outcomes worldwide. With a strong presence across both drug and device development, we operate at the forefront of combination products, integrating science, technology, and patient-centric design. Our teams are committed to advancing quality, compliance, and innovation across the product lifecycle, ensuring that every product meets the highest standards of safety, efficacy, and regulatory excellence.
Why join us?
This is a unique opportunity to work within a highly regulated and innovation-driven environment at the intersection of pharmaceuticals and medical devices. You will play a critical role in supporting combination product development and commercial programs that directly impact patients’ lives. You will be part of a collaborative, cross-functional team where your expertise in quality and compliance will help shape product development, influence regulatory strategy, and drive continuous improvement across complex systems.
POSITION OVERVIEW
We are seeking a Quality Engineer with experience in pharmaceutical, medical device, or combination product environments to support quality systems, design controls, and risk management activities. This role will partner closely with R&D, manufacturing, regulatory, and external partners to ensure compliance and quality throughout the product lifecycle.
KEY RESPONSIBILITIES
- Support design control and risk management activities for combination product development programs
- Ensure compliance with applicable quality and regulatory standards, including FDA and global requirements
- Partner with cross-functional teams to support product development, validation, and commercialization efforts
- Participate in risk assessments, including FMEA and hazard analyses, and support mitigation strategies
- Support design verification and validation activities, including human factors and usability considerations
- Contribute to regulatory submissions by supporting quality-related documentation and data
- Investigate quality issues and support root cause analysis and CAPA implementation
- Collaborate with external partners, including design firms and manufacturers, to ensure quality system alignment
- Support internal and external audits and inspections
- Identify and drive continuous improvement initiatives across quality systems and processes
QUALIFICATIONS
- Bachelor’s, Master’s, or PhD in Engineering or a related scientific discipline (e.g., Biomedical, Mechanical, Chemical, Materials, or Life Sciences)
- 3+ years of experience in pharmaceutical, medical device, or combination product environments
- Strong understanding of design controls and risk management principles
- Working knowledge of applicable standards and regulations, including ISO 13485, ISO 14971, 21 CFR 820, 21 CFR Part 4, and EU MDR
- Familiarity with Human Factors / Usability Engineering is preferred
- Understanding of Good Manufacturing Practices (GMP)
- Experience with validation, verification, and quality system processes
SKILLS AND COMPETENCIES
- Strong analytical and problem-solving skills with attention to detail
- Ability to manage multiple priorities in a fast-paced, regulated environment
- Effective collaboration across cross-functional and global teams
- Strong communication skills, both written and verbal
- Ability to work independently while maintaining alignment with broader project goals
- Proficiency in standard business tools and data analysis
Interested in hearing more? Easy Apply now by clicking the "Easy Apply" button.
Want to learn more about this role and Jobot?
Click our Jobot logo and follow our LinkedIn page!
How to Get Visa Sponsorship as a Quality Engineer
Confirm your degree qualifies for STEM OPT
Quality Engineer roles almost always qualify for the 24-month STEM OPT extension if your degree is in engineering, manufacturing, or a related STEM field. Verify your program's CIP code with your DSO before applying to maximize your authorization window.
Apply to industries with high OPT acceptance rates
Automotive, aerospace, semiconductor, and medical device companies hire Quality Engineers at scale and have established OPT and H-1B pipelines. These industries are far more accustomed to work authorization paperwork than smaller manufacturers or general contractors.
Highlight certifications that reduce employer hesitation
Certifications like ASQ CQE, Six Sigma Green Belt, or IATF 16949 familiarity signal job-readiness and reduce the perceived risk of sponsoring an OPT candidate. Even an in-progress certification is worth listing on your resume prominently.
Address OPT timing proactively in your application
Many Quality Engineer roles need someone who can start within weeks. Apply early and note your exact OPT start date and STEM extension eligibility in your cover letter so hiring managers understand your timeline without having to ask.
Emphasize compliance and documentation skills
Quality Engineers work inside heavily regulated environments where attention to detail is non-negotiable. Framing your academic and project experience around ISO standards, root cause analysis, or CAPA processes makes your profile immediately relevant to hiring managers.
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Get Access To All JobsFrequently Asked Questions
Can I work as a Quality Engineer on F-1 OPT?
Yes. Quality Engineer is a qualifying role for F-1 OPT as long as the work is directly related to your field of study. Most Quality Engineer positions in manufacturing, aerospace, or medical devices align with mechanical, industrial, or systems engineering degrees, which satisfies the OPT employment requirement. Confirm the match with your DSO before accepting an offer.
Does a Quality Engineer role qualify for the STEM OPT extension?
In most cases, yes. If your degree is in a STEM-designated field such as mechanical engineering, industrial engineering, or materials science, a Quality Engineer role typically qualifies for the 24-month STEM OPT extension, giving you up to 36 months of total work authorization. Your employer must also be enrolled in E-Verify, which most mid-size and large manufacturers already are.
How do I find Quality Engineer jobs that accept OPT students?
Migrate Mate is the best starting point. The platform is built specifically for F-1 OPT and visa-sponsored job seekers, so the Quality Engineer listings are filtered for employers open to work authorization. Searching there saves you from applying to roles where OPT will be screened out before your resume reaches a hiring manager.
What happens to my OPT authorization if my Quality Engineer job ends?
You have a 60-day grace period after your OPT employment ends to find a new qualifying job, transfer to another visa status, or depart the United States. During this window you cannot work. If you're on STEM OPT, the same 60-day rule applies. Notify your DSO immediately when employment ends so they can update your SEVIS record.
Do Quality Engineer employers typically sponsor H-1B visas after OPT?
Many do, particularly in automotive, aerospace, semiconductor, and medical device manufacturing, where Quality Engineers are in consistent demand and companies have established immigration processes. Sponsorship is not guaranteed, so it's worth asking directly during the offer stage. Targeting employers with a documented H-1B filing history significantly improves your chances of a long-term path.
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