Quality Specialist Visa Sponsorship Jobs in California
California is one of the most active states for quality specialist visa sponsorship, driven by its massive biotech, semiconductor, and medical device industries. Companies like Genentech, Apple, and Edwards Lifesciences regularly hire quality specialists in hubs like San Jose, San Diego, and the San Francisco Bay Area.
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Get Access To All JobsThe Post-Market QA Specialist plays a key role in ensuring the safety, effectiveness, and regulatory compliance of Hologic’s on-market molecular diagnostic products. The ideal candidate will be responsible for monitoring and facilitating the handling of post-market complaints as well as ensuring compliance with applicable industry regulations, standards, and company policy. The role may support product complaint investigations, including lab testing, risk assessment and root cause analysis across Hologic’s global molecular diagnostic product lines.
ESSENTIAL DUTIES AND RESPONSIBILITIES
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
Complaint Handling and Investigation:
- Receive, document, and process product complaints in compliance with Hologic SOPs and applicable regulatory requirements (FDA, ISO, EU MDR).
- Conduct initial assessments of complaints and work with cross-functional teams as needed to support timely investigation, root cause analysis, and resolution of complaints of moderate complexity.
- Ensure timely, accurate, and complete complaint records in the complaint management system.
- May support product complaint investigations, including lab testing, risk assessment, and root cause analysis as needed.
Regulatory Reporting:
- Identify and escalate potential adverse events to QA management.
- Support preparation and submission of regulatory reports (e.g., FDA MDR, EU Vigilance, FSCA/FSN) according to global regulatory requirements.
- Ensure post-market activities are compliant with Hologic’s quality system and all applicable standards.
Data Analysis & Trending:
- Sustain routine monitoring and trending of product performance, complaint data, adverse event reporting data, and quality KPI’s to identify and track potential product issues.
Audit & Inspection Support:
- Support internal and external audits related to post-market surveillance and complaint handling as needed.
- Maintain accurate and audit-ready documentation.
Training & Process Development:
- Contribute to the development and improvement of processes, SOPs, work instructions, and training materials related to post-market quality assurance.
- Train others as needed.
KNOWLEDGE
- Quality Systems: Working knowledge of post-market surveillance, complaint handling, risk management, and non-conformance / CAPA processes.
- Compliance: Familiarity with FDA QSR (21 CFR Part 820), ISO 13485, and global post-market surveillance requirements.
- Data Trending: Basic knowledge of tracking and trending product / process metrics and KPI’s with statistical methods and data visualization tools (e.g., Power BI), ideally for manufacturing or technical support of high volume products.
- Product Knowledge: Familiarity with processes and practices related to the design and manufacturing of in vitro diagnostic or medical device products, ideally with high volume automated reagent / hardware systems.
SKILLS
- Communication: aptitude to clearly explain data, processes, compliance requirements to cross-functional audiences in meetings, presentations, and reports.
- Organization: skilled at planning, executing, and managing tasks and processes to drive action individually and with others in a team setting.
- Data Analysis: aptitude to compile, research, and critically evaluate data to identify and understand patterns / trends as well as make informed conclusions.
BEHAVIORS
- Detail Oriented: proactively identifies and focuses on critical details needed to ensure accurate and high-quality results.
- Inquisitive: strong intellectual desire to understand and address technical issues by seeking information through asking probing questions, research, data analysis, and collaboration with others.
- Quality / Safety Focused: committed to ensuring product quality and safety by making and documenting objective conclusions based on data and facts.
- Resourceful: applies self-directed research, problem solving, critical thinking, collaboration skills to approach uncertainty and adapt to change.
REQUIREMENTS
- B.S. in scientific or engineering discipline.
- 3+ years of experience in a quality role within an ISO 13485 quality management system, ideally with focus on Post-Market Surveillance, complaint handling, and / or complaint trending.
- Prior experience supporting development and / or manufacturing of IVD or other medical device products preferred.
The annualized base salary range for this role is $71,000 - $104,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.
Why Hologic?
We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
If you have the right skills and experience, apply today!
LI-AV1
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
The Post-Market QA Specialist plays a key role in ensuring the safety, effectiveness, and regulatory compliance of Hologic’s on-market molecular diagnostic products. The ideal candidate will be responsible for monitoring and facilitating the handling of post-market complaints as well as ensuring compliance with applicable industry regulations, standards, and company policy. The role may support product complaint investigations, including lab testing, risk assessment and root cause analysis across Hologic’s global molecular diagnostic product lines.
ESSENTIAL DUTIES AND RESPONSIBILITIES
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
Complaint Handling and Investigation:
- Receive, document, and process product complaints in compliance with Hologic SOPs and applicable regulatory requirements (FDA, ISO, EU MDR).
- Conduct initial assessments of complaints and work with cross-functional teams as needed to support timely investigation, root cause analysis, and resolution of complaints of moderate complexity.
- Ensure timely, accurate, and complete complaint records in the complaint management system.
- May support product complaint investigations, including lab testing, risk assessment, and root cause analysis as needed.
Regulatory Reporting:
- Identify and escalate potential adverse events to QA management.
- Support preparation and submission of regulatory reports (e.g., FDA MDR, EU Vigilance, FSCA/FSN) according to global regulatory requirements.
- Ensure post-market activities are compliant with Hologic’s quality system and all applicable standards.
Data Analysis & Trending:
- Sustain routine monitoring and trending of product performance, complaint data, adverse event reporting data, and quality KPI’s to identify and track potential product issues.
Audit & Inspection Support:
- Support internal and external audits related to post-market surveillance and complaint handling as needed.
- Maintain accurate and audit-ready documentation.
Training & Process Development:
- Contribute to the development and improvement of processes, SOPs, work instructions, and training materials related to post-market quality assurance.
- Train others as needed.
KNOWLEDGE
- Quality Systems: Working knowledge of post-market surveillance, complaint handling, risk management, and non-conformance / CAPA processes.
- Compliance: Familiarity with FDA QSR (21 CFR Part 820), ISO 13485, and global post-market surveillance requirements.
- Data Trending: Basic knowledge of tracking and trending product / process metrics and KPI’s with statistical methods and data visualization tools (e.g., Power BI), ideally for manufacturing or technical support of high volume products.
- Product Knowledge: Familiarity with processes and practices related to the design and manufacturing of in vitro diagnostic or medical device products, ideally with high volume automated reagent / hardware systems.
SKILLS
- Communication: aptitude to clearly explain data, processes, compliance requirements to cross-functional audiences in meetings, presentations, and reports.
- Organization: skilled at planning, executing, and managing tasks and processes to drive action individually and with others in a team setting.
- Data Analysis: aptitude to compile, research, and critically evaluate data to identify and understand patterns / trends as well as make informed conclusions.
BEHAVIORS
- Detail Oriented: proactively identifies and focuses on critical details needed to ensure accurate and high-quality results.
- Inquisitive: strong intellectual desire to understand and address technical issues by seeking information through asking probing questions, research, data analysis, and collaboration with others.
- Quality / Safety Focused: committed to ensuring product quality and safety by making and documenting objective conclusions based on data and facts.
- Resourceful: applies self-directed research, problem solving, critical thinking, collaboration skills to approach uncertainty and adapt to change.
REQUIREMENTS
- B.S. in scientific or engineering discipline.
- 3+ years of experience in a quality role within an ISO 13485 quality management system, ideally with focus on Post-Market Surveillance, complaint handling, and / or complaint trending.
- Prior experience supporting development and / or manufacturing of IVD or other medical device products preferred.
The annualized base salary range for this role is $71,000 - $104,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.
Why Hologic?
We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
If you have the right skills and experience, apply today!
LI-AV1
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
Quality Specialist Job Roles in California
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Search Quality Specialist Jobs in CaliforniaQuality Specialist Jobs in California: Frequently Asked Questions
Which companies sponsor visas for quality specialists in California?
California's biotech and technology sectors produce some of the highest concentrations of quality specialist sponsorship in the country. Companies like Genentech, Gilead Sciences, Applied Materials, Intuitive Surgical, and Edwards Lifesciences have documented histories of sponsoring work visas for quality roles. Medical device manufacturers in San Diego and semiconductor firms in Silicon Valley are particularly active sponsors.
Which visa types are most common for quality specialist roles in California?
The H-1B visa is the most common visa for quality specialists in California, particularly for roles requiring a bachelor's degree in engineering, life sciences, or a related technical field. The employer must demonstrate the position qualifies as a specialty occupation. Some multinational companies also use the L-1B for intracompany transferees moving into quality engineering or compliance roles from overseas offices.
Which cities in California have the most quality specialist sponsorship jobs?
The San Francisco Bay Area, including San Jose and Santa Clara, leads in quality specialist sponsorship tied to semiconductor and tech manufacturing. San Diego is the primary hub for biotech and medical device quality roles, with a dense cluster of life sciences employers. Los Angeles also has a notable presence in aerospace and consumer electronics quality assurance hiring.
How to find quality specialist visa sponsorship jobs in California?
Migrate Mate filters job listings specifically for roles offering visa sponsorship, making it straightforward to identify quality specialist positions in California without sorting through companies that don't sponsor. You can narrow results by location, industry, and visa type. Given California's competitive hiring market in biotech and tech manufacturing, focusing your search on employers with established quality and compliance teams tends to yield the most relevant results.
Are there any California-specific considerations for quality specialists seeking visa sponsorship?
California's prevailing wage requirements under Department of Labor rules apply to H-1B quality specialist roles, and wages in Bay Area and San Diego markets tend to reflect high local cost of living. The state's concentration of FDA-regulated industries means many quality roles carry specific regulatory credentials as requirements. University programs at UC San Diego, UC Davis, and Cal Poly also feed strong domestic and international pipelines into California quality teams.
What is the prevailing wage for sponsored quality 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.