STEM OPT Senior Quality Manager Jobs
Senior Quality Manager roles in manufacturing, biotech, and medical devices align directly with STEM OPT eligibility. Your 24-month STEM OPT extension applies when the employer is enrolled in E-Verify and your degree falls under a qualifying CIP code. Engineering, applied sciences, and related technical fields typically meet that threshold.
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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 905+ STEM OPT Senior Quality Manager Jobs
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Get Access To All JobsTips for Finding STEM OPT Authorization as a Senior Quality Manager
Verify your CIP code before applying
Cross-check your degree against STEM-designated CIP codes on the official SEVP list before targeting roles. Quality engineering and industrial engineering degrees qualify; general business degrees usually don't, even if your coursework was technical.
Confirm E-Verify enrollment during screening
Ask recruiters directly whether the employer is enrolled in E-Verify before your first interview. Public employers and federal contractors are often enrolled by law, but smaller manufacturers and private-label producers frequently aren't.
Tailor your I-983 training plan to quality systems work
Map your I-983 learning objectives to specific quality frameworks you'll use on the job, such as ISO 9001, CAPA systems, or Six Sigma methodologies. Vague training plans get pushed back by DSOs and delay your extension authorization.
Target industries with structured quality functions
Biotech, aerospace, automotive, and medical device companies run formalized quality departments where STEM OPT students slot in with clear reporting structures. Pursue roles in these sectors rather than generalist operations positions with ambiguous quality responsibilities.
Use Migrate Mate to filter verified STEM OPT employers
Search Senior Quality Manager openings on Migrate Mate, which surfaces employers with confirmed E-Verify enrollment. This removes the manual verification step and lets you focus applications on companies already set up to hire STEM OPT workers.
Negotiate your start date around DSO processing time
Your employer must sign the I-983 before your extension is filed with USCIS, and DSO processing can add one to three weeks. Build that window into your offer negotiation so your authorization is in place before your start date.
Frequently Asked Questions
Does my STEM degree qualify me for the STEM OPT extension in a Senior Quality Manager role?
Your degree must appear on the SEVP-designated STEM CIP code list. Engineering disciplines like industrial, mechanical, chemical, and systems engineering qualify directly. Applied sciences degrees tied to manufacturing or laboratory work typically qualify as well. Confirm your specific CIP code with your DSO before accepting an offer, since the role title alone doesn't determine eligibility.
Does a Senior Quality Manager employer need to be enrolled in E-Verify?
Yes. E-Verify enrollment is a firm requirement for any employer hiring a STEM OPT student. Without active E-Verify enrollment, the employer cannot legally support your 24-month extension, regardless of how well the role fits your training. Verify enrollment status directly with the recruiter or through the E-Verify employer search before accepting an offer.
What should the I-983 training plan include for a Senior Quality Manager position?
The I-983 must connect your day-to-day quality management responsibilities to the knowledge you gained through your STEM degree. Specify the quality systems you'll manage, such as corrective action processes, audit programs, or regulatory compliance frameworks. Generic descriptions get rejected. Your employer's quality director typically needs to sign off, so involve them early in drafting the plan.
How does cap-gap protection apply if I'm in a Senior Quality Manager role and my employer files for H-1B?
If your OPT or STEM OPT expires while an H-1B visa petition is pending and you're selected in the lottery, cap-gap automatically extends your work authorization through September 30 of that fiscal year. You can continue working in your Senior Quality Manager role during this period without interruption. USCIS issues updated guidance each cycle, so confirm the current cap-gap rules with your DSO.
Where can I find Senior Quality Manager jobs that support STEM OPT?
Migrate Mate lists Senior Quality Manager openings filtered for employers with verified E-Verify enrollment, which is the baseline requirement for STEM OPT eligibility. Filtering by E-Verify status at the outset saves time compared to discovering mid-process that an employer isn't set up to support your extension. Start there before reaching out to individual companies.