Quality Systems Specialist Visa Sponsorship Jobs in California
Quality systems specialist visa sponsorship jobs in California span medical device manufacturers in the San Diego biotech corridor, semiconductor firms in Silicon Valley, and aerospace companies along the Los Angeles basin. Major employers including Boston Scientific, Thermo Fisher Scientific, and Broadcom have active quality and compliance teams that sponsor international candidates.
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About us:
For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.
Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!
Position Summary:
The Quality Systems Specialist II is responsible for ensuring operations adherence and compliance to Cirtec Medical's Quality Management System (QMS) requirements. Ensures compliant execution and coordination of system elements within the Quality Systems & Control functions team.
Key Responsibilities:
- Initiate, own, and/or close Nonconforming Material Reports (NCMRs).
- Initiate or Support investigation/analysis of returned/complaint materials.
- Coordinate activities related to NCM, Complaint, RMA, and CAPA processes.
- Support investigation and root cause analysis of advanced/complex issues.
- Escalate material nonconformances to CAPA system based on trending and monitoring analysis.
- Communicate product performance by formal presentations to management committees.
- Maintain quality system documents related to NCMR, CAPA, and Complaint systems.
- Initiate or review document changes including quality procedures.
- Review quality documentation and records and update as required.
- Consistently abide by and conforms to all established Cirtec Medical policies and procedures.
- Complete assigned tasks while operating independently and/or with minimal supervision.
- Respond and adapt to changing priorities with minimal disruption.
- Act as a CAPA Owner or support CAPA activities, as necessary, driving corrections and corrective actions to successful completion.
- Provide support to the Supplier Quality management group as needed.
- Provide support during internal audit and external audits.
- Ensure adherence to training requirements regarding Quality Management System elements, controls, processes, and procedures.
- Provide training, as needed, to individuals or groups on NCM Control, CAPA, etc.
- Support Corporate Quality Management System initiatives and continuous improvement activities.
- Calculate or monitor key quality metrics.
- Ensure compliance to regulatory standards and requirements as applicable.
- Ensure compliance of all site personnel to Corporate and site-level QMS and functional training requirements.
- Must be knowledgeable of, and adhere to, the Cirtec Medical Quality Management System and its requirements.
- Must be able to successfully meet Cirtec Medical-specific positional/functional on-the-job training requirements as provided.
- Must follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidelines and rules.
Must Have:
- Associates of Science Degree in Manufacturing, Engineering, or Technical Field, or equivalent of directly transferrable industry work experience.
- Experience examining the data for patterns and trends and working on cross-functional teams.
- A minimum of 2 years of relevant experience in a regulated manufacturing environment required.
- Knowledge of, and experience with, GMP/ISO Standards.
- Strong verbal and written English language communication skills.
- Must demonstrate ability and/or experience in computer use and general office software - Microsoft Office (i.e., Outlook, Word, Excel, and PowerPoint).
- “Hands-on” self-starter with ability to work both independently and as part of a team.
- Must be able to read, write and speak fluent English.
- Ability to work with a wide variety of functional areas, including R&D, Manufacturing, and QA, as required accomplishing results with minimal guidance.
Nice to Have:
- Advanced Post-Secondary Education/Training/Certification coursework (Manufacturing or Engineering discipline preferred) preferred.
- Quality certification(s) (e.g., ASQ CQT, CQI, etc.) preferred.
- Class I, II and/or III Medical Device manufacturing experience preferred or other regulated manufacturing industry experience (e.g., Aerospace, Automotive, Defense, Pharmaceutical, etc.).
- Experience working with PowerBI.
Salary Range: The pay range for this role is $84,000 - 100,000 a year. The successful candidate's starting base pay will be determined based on job-related skills experience qualifications work location and market conditions. The expected base pay range for this role may be modified based on market conditions.
Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.
We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec’s goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Description
About us:
For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.
Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!
Position Summary:
The Quality Systems Specialist II is responsible for ensuring operations adherence and compliance to Cirtec Medical's Quality Management System (QMS) requirements. Ensures compliant execution and coordination of system elements within the Quality Systems & Control functions team.
Key Responsibilities:
- Initiate, own, and/or close Nonconforming Material Reports (NCMRs).
- Initiate or Support investigation/analysis of returned/complaint materials.
- Coordinate activities related to NCM, Complaint, RMA, and CAPA processes.
- Support investigation and root cause analysis of advanced/complex issues.
- Escalate material nonconformances to CAPA system based on trending and monitoring analysis.
- Communicate product performance by formal presentations to management committees.
- Maintain quality system documents related to NCMR, CAPA, and Complaint systems.
- Initiate or review document changes including quality procedures.
- Review quality documentation and records and update as required.
- Consistently abide by and conforms to all established Cirtec Medical policies and procedures.
- Complete assigned tasks while operating independently and/or with minimal supervision.
- Respond and adapt to changing priorities with minimal disruption.
- Act as a CAPA Owner or support CAPA activities, as necessary, driving corrections and corrective actions to successful completion.
- Provide support to the Supplier Quality management group as needed.
- Provide support during internal audit and external audits.
- Ensure adherence to training requirements regarding Quality Management System elements, controls, processes, and procedures.
- Provide training, as needed, to individuals or groups on NCM Control, CAPA, etc.
- Support Corporate Quality Management System initiatives and continuous improvement activities.
- Calculate or monitor key quality metrics.
- Ensure compliance to regulatory standards and requirements as applicable.
- Ensure compliance of all site personnel to Corporate and site-level QMS and functional training requirements.
- Must be knowledgeable of, and adhere to, the Cirtec Medical Quality Management System and its requirements.
- Must be able to successfully meet Cirtec Medical-specific positional/functional on-the-job training requirements as provided.
- Must follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidelines and rules.
Must Have:
- Associates of Science Degree in Manufacturing, Engineering, or Technical Field, or equivalent of directly transferrable industry work experience.
- Experience examining the data for patterns and trends and working on cross-functional teams.
- A minimum of 2 years of relevant experience in a regulated manufacturing environment required.
- Knowledge of, and experience with, GMP/ISO Standards.
- Strong verbal and written English language communication skills.
- Must demonstrate ability and/or experience in computer use and general office software - Microsoft Office (i.e., Outlook, Word, Excel, and PowerPoint).
- “Hands-on” self-starter with ability to work both independently and as part of a team.
- Must be able to read, write and speak fluent English.
- Ability to work with a wide variety of functional areas, including R&D, Manufacturing, and QA, as required accomplishing results with minimal guidance.
Nice to Have:
- Advanced Post-Secondary Education/Training/Certification coursework (Manufacturing or Engineering discipline preferred) preferred.
- Quality certification(s) (e.g., ASQ CQT, CQI, etc.) preferred.
- Class I, II and/or III Medical Device manufacturing experience preferred or other regulated manufacturing industry experience (e.g., Aerospace, Automotive, Defense, Pharmaceutical, etc.).
- Experience working with PowerBI.
Salary Range: The pay range for this role is $84,000 - 100,000 a year. The successful candidate's starting base pay will be determined based on job-related skills experience qualifications work location and market conditions. The expected base pay range for this role may be modified based on market conditions.
Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.
We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec’s goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Quality Systems Specialist Job Roles in California
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Search Quality Systems Specialist Jobs in CaliforniaQuality Systems Specialist Jobs in California: Frequently Asked Questions
Which companies sponsor visas for quality systems specialists in California?
Medical device and life sciences companies are among the most active sponsors for quality systems specialists in California. Firms like Abbott, Becton Dickinson, Hologic, and Thermo Fisher Scientific have quality and regulatory affairs departments that regularly sponsor H-1B visa and EB-2 or EB-3 green card petitions. Aerospace and defense employers such as Northrop Grumman and Raytheon also sponsor quality engineers and compliance specialists at California facilities.
Which visa types realistically fit quality systems specialist roles in California?
Quality systems specialist roles typically qualify as specialty occupations requiring a bachelor's degree in engineering, life sciences, or a related technical field, making H-1B the most common path. Employers can also sponsor EB-2 or EB-3 employment-based green cards through the PERM labor certification process. Candidates on F-1 OPT or STEM OPT can work in quality systems roles if their degree is STEM-designated, with STEM OPT providing up to 24 additional months of authorization at E-Verify enrolled employers.
Which cities in California have the most quality systems specialist sponsorship jobs?
San Diego leads for quality systems specialists due to its dense concentration of medical device and biotech companies, particularly around the Torrey Pines and Sorrento Valley corridors. San Jose and Santa Clara see strong demand from semiconductor and electronics manufacturers. Los Angeles and its surrounding cities host aerospace and defense employers with active quality teams. San Francisco's biopharma sector also generates consistent demand for quality and compliance specialists.
How to find quality systems specialist visa sponsorship jobs in California?
Migrate Mate lists quality systems specialist roles at California employers with verified visa sponsorship history, letting you search by city and filter to companies with active H-1B LCA filing records. Focusing your search on medical device, semiconductor, and aerospace employers in San Diego, Silicon Valley, and Los Angeles will surface the highest concentration of sponsoring companies. Reviewing an employer's prior LCA filings is a reliable way to confirm sponsorship intent before applying.
Are there state-specific factors that affect visa sponsorship for quality systems specialists in California?
California's size and industry diversity create strong sponsorship conditions for quality systems specialists. The state's medical device and biotech cluster around San Diego, its semiconductor industry in Silicon Valley, and its aerospace corridor near Los Angeles each produce consistent H-1B and green card sponsorship. California also hosts several FDA regional offices, which drives demand for specialists with regulatory affairs and quality management system experience, particularly ISO 13485 and 21 CFR Part 820 compliance backgrounds.
What is the prevailing wage for sponsored quality systems specialist jobs in California?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.