STEM OPT Quality Engineer Jobs
Quality Engineer roles in manufacturing, medical devices, and aerospace qualify for the 24-month STEM OPT extension, giving you up to 36 months of F-1 work authorization. Your employer must be enrolled in E-Verify, and your degree in engineering, materials science, or a related STEM field makes you eligible.
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Argon Medical is a global manufacturer of specialty medical products, headquartered in Plano, Texas. Argon offers a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology and Oncology. Argon’s brand is recognized for best-in-class products that improve patient outcomes via percutaneous, image-guided procedures. Our values describe what we believe in and how we operate. These values are our moral compasses which guide our decisions and define the deeply held beliefs and principles of our organizational culture. Argon Medical is a family of individuals united by a mission and culture which continue to grow stronger every day.
ARGON MEDICAL DEVICES IS NOT LEVERAGING SEARCH FIRMS
Position Overview:
The Quality Engineer (Post-Market) – Complaints Investigator is responsible for investigating product complaints, evaluating product performance and safety issues, and supporting post-market quality activities to ensure compliance with applicable regulatory requirements and internal procedures. This role provides quality engineering support for complaint handling, post-market surveillance, risk management, regulatory reporting, and continuous improvement initiatives to ensure product quality, patient safety, and regulatory compliance throughout the product lifecycle.
What you will do:
Primary Duties
- Lead complaint evaluations and investigations to determine product failure modes, identify root causes, assess patient and user impact, and ensure timely closure of complaint records.
- Perform risk assessments associated with customer complaints, product performance issues, and adverse events to determine product safety impact and support risk management activities.
- Analyze complaint and post-market surveillance data to identify trends, emerging quality signals, and opportunities for product and process improvement.
- Assess complaints for reportability and support regulatory reporting activities, including Medical Device Reporting (MDR), Vigilance Reporting, Field Actions, and other applicable global regulatory requirements.
- Lead investigations of product nonconformances, quality issues, and product performance concerns identified through post-market monitoring activities.
- Collaborate with cross-functional teams, including Regulatory Affairs, Medical Affairs, Manufacturing, Engineering, and Customer Service, to investigate and resolve product quality issues.
- Initiate and support Corrective and Preventive Actions (CAPA), ensuring appropriate containment, root cause analysis, effectiveness verification, and documentation.
- Maintain and support risk management activities by evaluating complaint trends and post-market data for potential impacts to product risk profiles, hazard analyses, and risk management files.
- Ensure compliance with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, ISO 14971, Medical Device Reporting (MDR), Medical Device Vigilance, and other applicable global regulations.
Travel 5–10% as required.
Skills for Success:
- Bachelor’s degree in engineering, Life Sciences, Quality, or related technical field required.
- 3+ years of Quality Engineering, Complaint Investigation, Post-Market Surveillance, or Medical Device Quality Systems experience required.
- Experience conducting complaint investigations, root cause analysis, and product performance evaluations required.
- Strong knowledge of FDA Quality System Regulations, ISO 13485, ISO 14971, Medical Device Reporting (MDR), and post-market surveillance requirements required.
- Experience with CAPA, nonconformance management, risk assessment, and quality system processes required.
- Working knowledge of medical device adverse event reporting and regulatory compliance requirements are preferred.
- Strong analytical, technical writing, problem-solving, and communication skills required.
- Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent certification preferred.
- Experience supporting regulatory inspections and third-party audits preferred.
Company Overview:
Argon Medical is a global manufacturer of specialty medical products, headquartered in Plano, Texas. Argon offers a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology and Oncology. Argon’s brand is recognized for best-in-class products that improve patient outcomes via percutaneous, image-guided procedures. Our values describe what we believe in and how we operate. These values are our moral compasses which guide our decisions and define the deeply held beliefs and principles of our organizational culture. Argon Medical is a family of individuals united by a mission and culture which continue to grow stronger every day.
ARGON MEDICAL DEVICES IS NOT LEVERAGING SEARCH FIRMS
Position Overview:
The Quality Engineer (Post-Market) – Complaints Investigator is responsible for investigating product complaints, evaluating product performance and safety issues, and supporting post-market quality activities to ensure compliance with applicable regulatory requirements and internal procedures. This role provides quality engineering support for complaint handling, post-market surveillance, risk management, regulatory reporting, and continuous improvement initiatives to ensure product quality, patient safety, and regulatory compliance throughout the product lifecycle.
What you will do:
Primary Duties
- Lead complaint evaluations and investigations to determine product failure modes, identify root causes, assess patient and user impact, and ensure timely closure of complaint records.
- Perform risk assessments associated with customer complaints, product performance issues, and adverse events to determine product safety impact and support risk management activities.
- Analyze complaint and post-market surveillance data to identify trends, emerging quality signals, and opportunities for product and process improvement.
- Assess complaints for reportability and support regulatory reporting activities, including Medical Device Reporting (MDR), Vigilance Reporting, Field Actions, and other applicable global regulatory requirements.
- Lead investigations of product nonconformances, quality issues, and product performance concerns identified through post-market monitoring activities.
- Collaborate with cross-functional teams, including Regulatory Affairs, Medical Affairs, Manufacturing, Engineering, and Customer Service, to investigate and resolve product quality issues.
- Initiate and support Corrective and Preventive Actions (CAPA), ensuring appropriate containment, root cause analysis, effectiveness verification, and documentation.
- Maintain and support risk management activities by evaluating complaint trends and post-market data for potential impacts to product risk profiles, hazard analyses, and risk management files.
- Ensure compliance with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, ISO 14971, Medical Device Reporting (MDR), Medical Device Vigilance, and other applicable global regulations.
Travel 5–10% as required.
Skills for Success:
- Bachelor’s degree in engineering, Life Sciences, Quality, or related technical field required.
- 3+ years of Quality Engineering, Complaint Investigation, Post-Market Surveillance, or Medical Device Quality Systems experience required.
- Experience conducting complaint investigations, root cause analysis, and product performance evaluations required.
- Strong knowledge of FDA Quality System Regulations, ISO 13485, ISO 14971, Medical Device Reporting (MDR), and post-market surveillance requirements required.
- Experience with CAPA, nonconformance management, risk assessment, and quality system processes required.
- Working knowledge of medical device adverse event reporting and regulatory compliance requirements are preferred.
- Strong analytical, technical writing, problem-solving, and communication skills required.
- Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent certification preferred.
- Experience supporting regulatory inspections and third-party audits preferred.
See all 896+ STEM OPT Quality Engineer Jobs
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Get Access To All JobsTips for Finding STEM OPT Authorization as a Quality Engineer
Verify your CIP code before applying
Not every engineering degree automatically qualifies for STEM OPT. Check that your program's Classification of Instructional Programs code appears on the STEM Designated Degree Program list published by ICE before you file your extension with your DSO.
Target manufacturers with E-Verify enrollment
Quality Engineer roles are concentrated in regulated industries like medical devices, automotive, and aerospace. Before accepting an offer, confirm the hiring company is enrolled in E-Verify, since that enrollment is a hard legal requirement for your STEM OPT extension to be valid.
Use Migrate Mate to find verified openings
Searching broadly for Quality Engineer jobs wastes time on employers who won't meet the E-Verify requirement. Migrate Mate filters for employers with active work authorization history so you're only seeing roles where STEM OPT authorization is actually feasible.
Draft your I-983 training plan early
Many employers don't know what a Form I-983 training plan requires until you raise it. Bring a draft to the offer negotiation stage that maps your Quality Engineer duties to specific STEM learning objectives, so your employer isn't surprised after signing the offer letter.
Benchmark your offer against prevailing wage data
STEM OPT doesn't carry a formal prevailing wage mandate the way H-1B visa does, but underpayment relative to similarly situated workers can create problems. Run your job title and location through the OFLC Wage Search and the Bureau of Labor Statistics before evaluating any offer.
Understand cap-gap timing if H-1B is next
If your employer files an H-1B petition for you before your STEM OPT expires and you're selected in the lottery, cap-gap automatically extends your work authorization through September 30. Coordinate your OPT end date and the H-1B filing timeline with your DSO so there's no gap in authorization.
Frequently Asked Questions
Does a Quality Engineer role qualify for the STEM OPT extension?
Yes, if your degree is in an eligible STEM field such as industrial engineering, mechanical engineering, materials science, or manufacturing engineering, and your degree's CIP code appears on the ICE STEM Designated Degree Program list. The Quality Engineer role itself must also provide a direct connection to your STEM field of study, which you document in the Form I-983 training plan your employer signs.
Does my Quality Engineer employer need to be enrolled in E-Verify?
Yes, E-Verify enrollment is a mandatory legal requirement for any employer hiring a STEM OPT student. If the employer is not enrolled, your DSO cannot authorize the extension regardless of how well the role fits your degree. Ask your recruiter or HR contact to confirm E-Verify enrollment before you accept an offer, and verify the employer's status directly through the E-Verify employer search tool.
What goes into the I-983 training plan for a Quality Engineer position?
The Form I-983 requires your employer to describe specific learning objectives tied to your STEM degree, identify a supervisor responsible for your training, and confirm the company will report material changes in your role or employment status. For Quality Engineer roles, training objectives typically cover statistical process control, root cause analysis methods, and regulatory compliance systems like ISO 9001 or FDA quality regulations. Both you and your employer sign the form, and your DSO reviews and approves it.
How do I find Quality Engineer jobs where STEM OPT is actually viable?
The two barriers most STEM OPT students hit are employers who aren't enrolled in E-Verify and employers unfamiliar with the I-983 training plan requirement. Migrate Mate surfaces Quality Engineer openings from employers with documented work authorization history, so you can focus your search on companies that already understand the process rather than spending weeks educating HR from scratch.
What happens to my STEM OPT if my employer files an H-1B petition for me?
If your employer files a timely H-1B petition before your STEM OPT end date and USCIS selects you in the lottery, cap-gap protection automatically extends your OPT work authorization through September 30 of that year. If your petition is not selected or not filed in time, your authorization ends with your OPT period. Work with your DSO and your employer well in advance of the filing window to coordinate timing.