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Fda Inspector Jobs in Fremont, CA (NOW HIRING)

Penumbra

Sr Quality Engineer - Electronics

Alameda, CA

$125K - $175K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Support activities during FDA inspections, FDB inspections, and notified body audits. * Participate in the development of standard operating procedures. * Prepare documentation for inspection/testing ...

Alexza

VP Quality & Regulatory Affairs

Fremont, CA · On-site

Ensure company readiness for regulatory inspections and serve as executive quality representative during FDA, EMA, and other regulatory inspections. * Ensure quality system metrics and key process ...

Penumbra

Sr Quality Engineer - Electronics

Alameda, CA · On-site

$125K - $175K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

... FDA inspections, FDB inspections, and notified body audits. * • Participate in the development of standard operating procedures. * • Prepare documentation for inspection/testing procedures. * • ...

Socket.dev

Senior Director, Quality

Foster City, CA · On-site

$180 - $260/hr

... ICH, FDA, EMA, and GxP guidelines (GCP, GMP, GLP). * Lead internal quality audits, host regulatory agency inspections, and manage all associated audit responses and CAPAs. * Oversee deviation ...

New

Tempus

Senior Quality Engineer

Redwood City, CA · On-site +1

Be involved in the medical device software design controls activities, in accordance with the FDA ... external inspections and regulatory and customer audits. * Provide CSV guidance, coaching ...

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Showing results 21-40

All JobsFda Inspector JobsFda Inspector Jobs in Fremont, CA

Fda Inspector information

See Fremont, CA salary details

$26.8K

$60.1K

$108.4K

How much do fda inspector jobs pay per year?

As of Aug 18, 2026, the average yearly pay for fda inspector in Fremont, CA is $60,140.00, according to ZipRecruiter salary data. Most workers in this role earn between $42,100.00 and $69,500.00 per year, depending on experience, location, and employer.

What does an FDA inspector do?

An FDA Inspector is responsible for ensuring that companies comply with federal regulations related to food, drugs, medical devices, and other products overseen by the U.S. Food and Drug Administration. They conduct inspections, review records, collect samples, and assess manufacturing practices to ensure public health and safety. Inspectors may also investigate complaints, issue compliance notices, and recommend enforcement actions if violations are found.

What skills and qualifications are needed to be an FDA inspector?

To thrive as an FDA Inspector, you need a solid background in science or public health, attention to detail, and thorough knowledge of regulatory standards, often supported by a relevant degree. Familiarity with inspection protocols, laboratory testing equipment, and digital reporting systems is commonly required, along with potential USDA or FDA certifications. Strong analytical thinking, effective communication, and integrity are important soft skills for this role. These competencies ensure accurate inspections, compliance with safety regulations, and clear reporting essential to public health and organizational accountability.

What types of facilities or products do FDA inspectors review, and what does a typical inspection process involve?

FDA Inspectors routinely examine a variety of facilities, such as food processing plants, pharmaceutical manufacturers, medical device companies, and cosmetic production sites, to ensure compliance with federal safety and quality regulations. A typical inspection involves reviewing operational procedures, examining production environments, sampling products, and interviewing staff to identify potential violations or risks. Inspectors often work onsite, sometimes with travel required to cover multiple locations within their region, and collaborate closely with facility management to explain findings and recommend corrective actions. This role offers the opportunity to make a significant impact on public health and provides clear advancement pathways into specialized inspection or supervisory roles within regulatory agencies.

How do you become an FDA inspector?

To become an FDA inspector, candidates typically need a bachelor's degree in a relevant field such as biology, chemistry, or food science, along with experience in food safety, pharmaceuticals, or related areas. They must pass a written exam and a background check, and often undergo specialized training at the FDA's training center. Certification or licensing is not required but can enhance prospects in the field.

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For Fda Inspector jobs in Fremont, CA, the most frequently searched job titles are:

What job categories do people searching Fda Inspector jobs in Fremont, CA look for?

The top searched job categories for Fda Inspector jobs in Fremont, CA are:

What cities near Fremont, CA are hiring for Fda Inspector jobs?

Cities near Fremont, CA with the most Fda Inspector job openings:

Fda Inspector jobs near you
Infographic showing various Fda Inspector job openings in Fremont, CA as of August 2026, with employment types broken down into 1% As Needed, 80% Full Time, 14% Part Time, 4% Contract, and 1% Nights. Highlights an 89% Physical, 2% Hybrid, and 9% Remote job distribution, with an average salary of $60,140 per year, or $28.9 per hour.

Sr Quality Engineer - Electronics

Penumbra

Alameda, CA

$125K - $175K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 9 days ago

Penumbra rating

7.8

Company rating: 7.8 out of 10

Based on 28 frontline employees who took The Breakroom Quiz

Job description

General Summary
The Senior Quality Engineer role is for a fully qualified engineer in all conventional aspects and functional areas. Plan and conduct work requiring judgment and independent evaluation along with selection and adaptation or modification of standard techniques, procedures, and criteria. Devise new approaches to problems encountered. Develop quality standards, application, revision, and maintenance for manufacturing. Monitor design control and provide quality assurance support. Work independently with general instructions toward the objectives expected. Receive technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects. Communicate and implement quality objectives.
 
Specific Duties and Responsibilities
Participate in the development and qualification activities for new and existing products.*
Lead and participate in project teams coordinating the quality efforts to design, develop, and continuously improve products.  Plan, schedule, conduct, or coordinate detailed phases of the engineering work for projects with various scopes. *
Perform work which involves conventional engineering practice but may include a variety of complex features, such as conflicting design requirements, unsuitability of standard materials, and difficult coordination requirements. *
Perform engineering work including one or more of the following:
Design and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of equipment
Develop and validate measurement methods
Monitor design control to assure that new products meet guidelines, develop success measurements, and maintain currency with design control standards per regulatory and industry standards
Support developmental projects in the area of quality assurance
Analyze reports and returned products and recommend corrective and preventive action
Perform statistical analysis and determine the responsibility for products or materials that do not meet required standards and specifications
Participate in NCR or CAPA board as necessary
Assist in and perform QSR training. *
Support activities during FDA inspections, FDB inspections, and notified body audits. *
Participate in the development of standard operating procedures. *
Prepare documentation for inspection/testing procedures. *
Perform responsibilities required by the Quality System and other duties as assigned.
Select, manage, train, and develop staff. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans. *
Adhere to the Company's Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. * 
Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. * 
Ensure other members of the department follow the QMS, regulations, standards, and procedures. * 
Perform other work-related duties as assigned.
*Indicates an essential function of the role
 
 
Position Qualifications
Minimum education and experience:
Bachelor's degree in Engineering, a Life Science or related field with 5+ years or relevant experience, including experience in Quality Assurance and ISO, or an equivalent combination of education and experience, preferably in a medical device or regulated industry environment
 
Additional qualifications:     
Advanced degree preferred
Experience applying IEC 60601 standards in a medical device environment preferred
Experience with Process Failure Mode and Effects Analysis (PFMEA), sustaining projects, commercial medical device manufacturing, Non-Conformance Reports (NCRs), Failure Investigations, and Change Control
Experience in auditing, design review, sterilization, project management, and/or product development highly desired  
Experience with Electronic devices and or PCBAs
Experience with Contract Manufactured Electromechanical Medical device products
 
Working Conditions
General office, laboratory, and cleanroom environments.
Business travel from 0% - 10%. 
Potential exposure to blood-borne pathogens. 
Requires some lifting and moving of up to 25 pounds. 
Must be able to move between buildings and floors. 
Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.  
Must be able to read, prepare emails, and produce documents and spreadsheets.   
Must be able to move within the office and access file cabinets or supplies, as needed. 
Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.  
 
 
Location and Pay
Alameda, CA
Annual Base Salary Range: $125,000 to $175,000

We offer a competitive compensation package plus a benefits and equity program, when applicable.

Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

 
 
What We Offer
A collaborative teamwork environment where learning is constant, and performance is rewarded.
The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).
 
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
 
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
 
If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.
 
For additional information on Penumbra's commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
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