OPT Quality Specialist Jobs
Quality Specialist roles are a strong fit for F-1 OPT students with backgrounds in engineering, manufacturing, or life sciences. Most positions qualify as STEM OPT extensions, giving you up to three years of work authorization. Employers in regulated industries like medical devices, pharmaceuticals, and aerospace routinely hire OPT candidates for quality assurance and compliance work.
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Get Access To All JobsWhy join Stryker?
Looking for a place that values your unique talents? Discover Stryker's award-winning culture.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
Job description
We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more: US Stryker employee benefits.
As the Quality System Specialist you will support the development of the quality management system in accordance with relevant regulatory requirements for medical devices. Oversee, support, and ensure that an effective and efficient quality management system is built and maintained. Responsibility for ensuring that all applicable quality system regulations are met in order to receive regulatory clearance/certification. This role is Hybrid in Redmond, Washington.
What you will do
- Support QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, ISO, MDD, and individual country requirements).
- Manage documents and document changes throughout QMS document lifecycle within electronic documentation system.
- Facilitate engineering documentation management within electronic documentation system including DMR, DHF and technical standards.
- Perform change control/configuration management checks to engineering documentation to ensure compliance with local procedures.
- Administer and maintain the electronic document management system, ensuring user access, permissions, and training records remain current.
- Perform document control checks to ensure documents and document changes comply with local procedures.
- Provide guidance to process owners, document creators, document reviewers and document approvers on the overall process and electronic management system.
- Identify improvements and inputs into the quality planning process.
- Execute development and/or modifications of Stryker’s QMS.
- Support Management Review and Quality Planning Review and related forums.
- Support GMP and GDP within Quality organization.
- Support QMS training development and delivery.
- Support implementation of best-in-class practices and benchmark against industry leaders and regulatory requirements.
- Support notified body communication.
- Ensure QMS reflects actual activities, business needs and supports NPD requirement.
- Coordinate internal and external audits, including securing conference rooms, communicating with SPOs/SMEs, and coordinating front room/back room logistics.
- Support internal and external audits by providing documentation and ensuring records are complete, accurate, and retrievable.
What you need
- Bachelor’s Degree in a science, engineering or related discipline, or equivalent experience.
- 0-2 years experience in manufacturing environment or equivalent.
Preferred
- Minimum of 2 years experience in area of quality systems, engineering, or equivalent experience preferred.
- Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.).
- Demonstrated knowledge of U.S., European, and international regulatory industry guidelines/standards and ability to interpret and apply.
- Knowledge and understanding of U.S. and International medical device regulations.
- Knowledge of supporting Quality Systems (audits, management review, quality planning, etc.).
- Strong communication, project management and influencing skills and have the ability to manage multiple tasks simultaneously.
- Strong written and oral communication and negotiation skills.
- Strong critical thinking skills.
- Developed problem-solving skills.
- Strong analytical skills.
- Demonstrated ability to successfully manage and complete projects in a matrix organization.
- Demonstrated ability to work independently.
- Experience working in a compliance-risk situation.
- Computer literacy, including Microsoft Word, Excel and PowerPoint.
- Some travel may be required.
United States of America Pay Ranges:
- US15: $76,500 - $117,100 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
Why join Stryker?
Looking for a place that values your unique talents? Discover Stryker's award-winning culture.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
Job description
We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more: US Stryker employee benefits.
As the Quality System Specialist you will support the development of the quality management system in accordance with relevant regulatory requirements for medical devices. Oversee, support, and ensure that an effective and efficient quality management system is built and maintained. Responsibility for ensuring that all applicable quality system regulations are met in order to receive regulatory clearance/certification. This role is Hybrid in Redmond, Washington.
What you will do
- Support QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, ISO, MDD, and individual country requirements).
- Manage documents and document changes throughout QMS document lifecycle within electronic documentation system.
- Facilitate engineering documentation management within electronic documentation system including DMR, DHF and technical standards.
- Perform change control/configuration management checks to engineering documentation to ensure compliance with local procedures.
- Administer and maintain the electronic document management system, ensuring user access, permissions, and training records remain current.
- Perform document control checks to ensure documents and document changes comply with local procedures.
- Provide guidance to process owners, document creators, document reviewers and document approvers on the overall process and electronic management system.
- Identify improvements and inputs into the quality planning process.
- Execute development and/or modifications of Stryker’s QMS.
- Support Management Review and Quality Planning Review and related forums.
- Support GMP and GDP within Quality organization.
- Support QMS training development and delivery.
- Support implementation of best-in-class practices and benchmark against industry leaders and regulatory requirements.
- Support notified body communication.
- Ensure QMS reflects actual activities, business needs and supports NPD requirement.
- Coordinate internal and external audits, including securing conference rooms, communicating with SPOs/SMEs, and coordinating front room/back room logistics.
- Support internal and external audits by providing documentation and ensuring records are complete, accurate, and retrievable.
What you need
- Bachelor’s Degree in a science, engineering or related discipline, or equivalent experience.
- 0-2 years experience in manufacturing environment or equivalent.
Preferred
- Minimum of 2 years experience in area of quality systems, engineering, or equivalent experience preferred.
- Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.).
- Demonstrated knowledge of U.S., European, and international regulatory industry guidelines/standards and ability to interpret and apply.
- Knowledge and understanding of U.S. and International medical device regulations.
- Knowledge of supporting Quality Systems (audits, management review, quality planning, etc.).
- Strong communication, project management and influencing skills and have the ability to manage multiple tasks simultaneously.
- Strong written and oral communication and negotiation skills.
- Strong critical thinking skills.
- Developed problem-solving skills.
- Strong analytical skills.
- Demonstrated ability to successfully manage and complete projects in a matrix organization.
- Demonstrated ability to work independently.
- Experience working in a compliance-risk situation.
- Computer literacy, including Microsoft Word, Excel and PowerPoint.
- Some travel may be required.
United States of America Pay Ranges:
- US15: $76,500 - $117,100 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
See all 272+ OPT Quality Specialist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Quality Specialist Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship as a Quality Specialist
Target STEM-designated programs
Quality Specialist roles in engineering and sciences typically qualify for the 24-month STEM OPT extension. Confirm your degree CIP code is STEM-eligible before applying so you can honestly communicate your full three-year authorization window to employers.
Lead with regulatory knowledge
Employers in FDA-regulated industries prioritize candidates who understand ISO 9001, GMP, or 21 CFR Part 820. Highlight any coursework, lab experience, or internships involving quality management systems, audits, or corrective action processes directly in your resume summary.
Address OPT proactively in applications
Hiring managers often hesitate because they misunderstand OPT. State clearly in your cover letter that OPT requires no employer sponsorship cost or petition during the authorization period, and that STEM extension gives them three years of work authorization.
Pursue quality certifications
A Certified Quality Improvement Associate or Six Sigma Green Belt certification signals serious commitment to the field. These credentials reduce employer hesitation about OPT candidates because they demonstrate measurable professional investment beyond your degree alone.
Focus on industries with high OPT hire rates
Medical devices, automotive, aerospace, and contract manufacturing firms consistently hire OPT students for quality roles. These industries operate under strict compliance requirements and value technically trained candidates, making them more comfortable navigating work authorization paperwork.
Quantify quality impact on your resume
Generic quality descriptions lose hiring managers fast. Cite specific outcomes: defect reduction percentages, audit pass rates, or process improvement results. Concrete metrics make your application competitive against domestic candidates and demonstrate real-world quality systems experience.
Quality Specialist OPT: Frequently Asked Questions
Do Quality Specialist employers need to sponsor F-1 OPT students?
No. During your OPT period, you already have work authorization through USCIS. Your employer does not file any petition or pay any sponsorship fee. For STEM OPT extension, your employer must be E-Verify enrolled and sign a training plan, but that is not the same as visa sponsorship. You can browse OPT-friendly Quality Specialist openings directly on Migrate Mate.
Does a Quality Specialist role qualify for the STEM OPT extension?
Most do, provided your underlying degree is in a STEM-designated field such as industrial engineering, mechanical engineering, chemistry, or biology. The job itself does not need to be classified as STEM, but it must be directly related to your degree program. Review your degree's CIP code with your DSO before applying to confirm STEM eligibility.
What degree backgrounds are most relevant for Quality Specialist OPT jobs?
Industrial engineering, mechanical engineering, biomedical engineering, chemistry, biochemistry, and manufacturing technology are the most common degree backgrounds. Life sciences degrees are especially relevant for pharmaceutical and medical device quality roles. Employers in regulated industries expect your coursework to connect directly to quality management, statistics, or process control concepts.
How does the 90-day unemployment rule affect Quality Specialist job searches?
USCIS allows no more than 90 cumulative days of unemployment during standard OPT and an additional 60 days during STEM OPT extension. Quality Specialist roles can take time to secure because many positions require industry-specific experience. Start your search early, track your unemployment days carefully, and target regulated industries where hiring timelines tend to move faster.
Can I work for a staffing agency or contract firm as a Quality Specialist on OPT?
Yes, third-party placement is generally permitted on OPT as long as there is a bona fide employer-employee relationship and the work is related to your degree. For STEM OPT specifically, the end client site must also be E-Verify enrolled. Confirm with your DSO before accepting any contract arrangement to ensure your training plan meets USCIS requirements.