STEM OPT Quality Manager Jobs
Quality Manager roles in manufacturing, biotech, and engineering align directly with STEM OPT eligibility, giving you up to 36 months of work authorization to build your career. Your employer must be enrolled in E-Verify to hire you, and your training plan must connect your STEM degree to the quality systems work you'll perform.
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Get Access To All JobsCompany 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.
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 904+ STEM OPT Quality Manager Jobs
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Get Access To All JobsTips for Finding STEM OPT Authorization as a Quality Manager
Verify your CIP code before applying
STEM OPT eligibility depends on your degree's Classification of Instructional Programs code, not just the degree name. Cross-reference your I-20's CIP code against the DHS STEM Designated Degree Program List before targeting Quality Manager roles.
Confirm E-Verify enrollment before accepting offers
Your employer must be actively enrolled in E-Verify before you can start on STEM OPT extension. Check the E-Verify employer search tool directly to confirm enrollment status, not just the recruiter's word during negotiations.
Target manufacturers with ISO or FDA audit history
Quality Manager roles at ISO 9001-certified manufacturers and FDA-regulated facilities map cleanly to STEM OPT training plans because the quality systems work ties directly to engineering or science degrees, reducing I-983 approval friction with your DSO.
Build your I-983 training plan around measurable outcomes
Your DSO approves the I-983, so frame your Quality Manager duties in terms of specific STEM learning objectives: SPC analysis, CAPA methodology, or process validation. Vague job descriptions create back-and-forth delays that push back your start date.
Use Migrate Mate to filter for E-Verify employers
Search Quality Manager roles on Migrate Mate, which filters positions by E-Verify enrollment status using DOL Labor Condition Application data. This removes the manual verification step and surfaces employers already set up to hire STEM OPT students.
Start H-1B cap-gap planning before your OPT expires
If your employer files an H-1B visa petition before your STEM OPT ends and you're selected in the lottery, cap-gap protection extends your work authorization through September 30. Coordinate your Quality Manager contract renewal timeline with your employer's USCIS filing calendar accordingly.
Frequently Asked Questions
Does a Quality Manager role qualify for STEM OPT extension?
Yes, if your degree carries a qualifying CIP code and your job duties connect directly to that STEM field. Quality Manager roles in manufacturing, engineering, or life sciences typically qualify because the work involves statistical process control, process engineering, or regulatory compliance grounded in STEM methodology. Your DSO makes the final determination when reviewing your I-983 training plan.
What must the I-983 training plan include for a Quality Manager position?
The I-983 must identify specific STEM learning objectives tied to your degree, not just a job description. For a Quality Manager, that means documenting how the role advances knowledge in areas like failure mode analysis, quality system design, or metrology. Your employer's supervisor signs off, your DSO reviews it, and USCIS can audit it at any point during your extension.
How do I confirm my employer is enrolled in E-Verify before my STEM OPT starts?
E-Verify enrollment is a legal prerequisite, not a formality. Use the E-Verify employer search tool to look up your employer's company name and confirm active participation status. Enrollment must be in place before your STEM OPT extension start date. If your employer isn't listed, they need to enroll before you can begin work under the extension.
What STEM degrees are typically eligible for Quality Manager STEM OPT roles?
Engineering disciplines (mechanical, industrial, chemical, electrical), materials science, physics, applied mathematics, and life sciences degrees commonly map to Quality Manager roles because the work involves quantitative analysis, process systems, and technical documentation. Your specific CIP code determines eligibility, so verify it on the DHS STEM Designated Degree Program List against your I-20 before targeting these positions.
Where can I find Quality Manager jobs where employers are already set up to hire STEM OPT students?
Migrate Mate filters Quality Manager roles by employers with E-Verify enrollment and DOL filing history, so you're not guessing about sponsorship willingness. This is especially useful for STEM OPT students because many employers support OPT work authorization but aren't yet familiar with the I-983 process, and filtering by verified E-Verify enrollment removes a significant screening step.