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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INTRODUCTION
At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.
The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.
At ZOLL, you won't just have a job. You'll have a career—and a purpose.
Join our team. It's a great time to be a part of ZOLL!
Job Type
Hybrid
JOB SUMMARY
The Product Quality Assurance Engineer supports product quality throughout the product lifecycle, with a focus on complaint investigations, risk management support, and product quality monitoring. This role partners with Engineering, Manufacturing, Regulatory, and Post-Market teams to support investigations, analyze product performance, and contribute to activities that improve product reliability, patient safety, and compliance for medical devices.
ESSENTIAL FUNCTIONS
- Assist with product and complaint investigations, including data gathering, product failure analysis, and support for root cause analysis activities.
- Support product risk management activities, including documentation updates, risk assessments, and maintenance of risk management files in accordance with applicable standards and procedures.
- Analyze complaint, service, and field performance data to identify trends, recurring issues, and opportunities for product quality improvement.
- Support CAPA and nonconformance activities related to product quality issues, including documentation, tracking, and follow-up actions.
- Participate in product design reviews and quality assessments to help ensure quality requirements are addressed throughout the product lifecycle.
- Partner with Design Assurance, R&D, Manufacturing, Supplier Quality, Regulatory Affairs, and Clinical/Post-Market teams to support resolution of product quality issues.
- Support design verification and validation quality activities through review of documentation and participation in related quality processes.
- Ensure product quality activities are performed in compliance with applicable regulatory requirements, quality system standards, and internal procedures.
- Maintain clear, accurate, and timely documentation of investigations, analyses, and quality records.
- Contribute to continuous improvement initiatives related to product quality, field performance, and quality system effectiveness.
EDUCATION AND EXPERIENCE
- Bachelor's Degree in Engineering or a related technical discipline.
- 2+ years of experience in quality engineering, product quality, or product engineering, preferably in a regulated industry.
- Internship, co-op, or early career experience in medical devices, manufacturing, or a regulated industry.
- Experience using quality system tools or data analysis tools is a plus.
KNOWLEDGE, SKILLS AND ABILITIES
- Basic understanding of engineering principles, data analysis, and problem-solving techniques.
- Strong organizational skills and attention to detail, with the ability to manage documentation and follow established processes.
- Ability to work collaboratively in a cross-functional team environment.
- Strong written and verbal communication skills, with the ability to clearly document findings and communicate with technical stakeholders.
- Ability to work effectively in a remote environment while collaborating across teams and time zones.
- Familiarity with complaint handling, CAPA, nonconformance systems, or risk management processes.
- Exposure to medical device design controls, verification and validation, or post-market quality activities.
- Knowledge of FDA Quality System requirements, ISO 13485, or ISO 14971 is a plus.
PREFERRED LANGUAGES
English - Advanced
TRAVEL REQUIREMENTS
Hybrid/Remote role with occasional travel as needed for team meetings, training, investigations, audits, or site support.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Standing - Occasionally
- Walking - Occasionally
- Sitting - Constantly
- Talking - Occasionally
- Hearing - Occasionally
- Repetitive Motions - Frequently
ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.
The annual salary for this position is:
$85,000.00 to $100,000.00
This position is eligible for an annual bonus in accordance with the company's bonus plan. Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.
Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee’s primary work location.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran.
ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.
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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.