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Remote Fda Auditor Jobs in Riverside, CA (NOW HIRING)

Prismatik

Document Control Specialist

Irvine, CA · On-site +1

$23 - $25/hr

Assists in Food and Drug Administration (FDA) inspections and Notified Body audits regarding ... Ensures accurate and timely input of database entries; implements a self-auditing system to verify ...

All JobsFda Auditor JobsRemote Fda Auditor JobsRemote Fda Auditor Jobs in Riverside, CA

Remote Fda Auditor information

See Riverside, CA salary details

$34.4K

$79.6K

$126.8K

How much do remote fda auditor jobs pay per year?

As of Aug 27, 2026, the average yearly pay for remote fda auditor in Riverside, CA is $79,555.00, according to ZipRecruiter salary data. Most workers in this role earn between $55,800.00 and $102,800.00 per year, depending on experience, location, and employer.

What is a remote FDA auditor?

Remote FDA Auditors are professionals who conduct audits and inspections of facilities, processes, and documentation to ensure compliance with the U.S. Food and Drug Administration (FDA) regulations, but they do so virtually rather than on site. Using digital tools and secure platforms, they review records, interview staff, and assess procedures from a remote location. This approach increases flexibility and efficiency while maintaining the integrity of compliance checks. Remote FDA Auditors are especially vital for organizations in the pharmaceutical, biotech, food, and medical device industries that must adhere to FDA standards.

What are the key skills and qualifications needed to thrive as a remote FDA auditor?

To thrive as a Remote FDA Auditor, you need a deep understanding of FDA regulations, auditing procedures, and quality management systems, typically supported by a degree in life sciences or a related field. Familiarity with electronic audit management tools, documentation systems, and relevant certifications such as Certified Quality Auditor (CQA) are highly valuable. Strong attention to detail, analytical thinking, and effective virtual communication are crucial soft skills for this role. These competencies ensure accurate compliance assessments, clear reporting, and effective collaboration while working remotely.

What are some common challenges faced by remote FDA auditors, and how can they be managed effectively?

Remote FDA Auditors often encounter challenges such as limited access to physical documents, time zone differences with global clients, and ensuring secure communication. To manage these effectively, auditors should familiarize themselves with digital audit tools, establish clear communication protocols with clients, and stay updated on remote auditing best practices. Proactive planning and strong organizational skills are essential for success in this role.

What is the difference between Remote Fda Auditor vs Remote Quality Assurance Specialist?

AspectRemote Fda AuditorRemote Quality Assurance Specialist
CertificationsFDA auditor certification, GxP, GMP, GLPISO, Six Sigma, GMP, GCP
Work EnvironmentRegulatory agencies, pharmaceutical, biotech companiesManufacturing, clinical trials, healthcare companies
Industry UsagePrimarily in pharma, biotech, medical devicesBroader across healthcare, manufacturing, biotech

The Remote Fda Auditor focuses on ensuring compliance with FDA regulations through audits of facilities and processes, mainly in pharma and biotech industries. The Remote Quality Assurance Specialist oversees quality systems, policies, and procedures across various healthcare sectors. While both roles require knowledge of GMP and regulatory standards, the Fda Auditor emphasizes compliance verification, whereas the QA Specialist concentrates on maintaining quality standards throughout the organization.

How do you become a remote FDA auditor?

To become a remote FDA auditor, candidates typically need a background in life sciences, healthcare, or quality assurance, along with experience in regulatory compliance. Earning certifications such as RAC or ISO auditor training can enhance prospects, and strong knowledge of FDA regulations and audit procedures is essential. Many roles require prior industry experience and familiarity with remote auditing tools and documentation practices.

What are popular job titles related to Remote Fda Auditor jobs in Riverside, CA?

For Remote Fda Auditor jobs in Riverside, CA, the most frequently searched job titles are:

What job categories do people searching Remote Fda Auditor jobs in Riverside, CA look for?

The top searched job categories for Remote Fda Auditor jobs in Riverside, CA are:

What cities near Riverside, CA are hiring for Remote Fda Auditor jobs?

Cities near Riverside, CA with the most Remote Fda Auditor job openings:

Remote Fda Auditor jobs near you

Sr. Quality Assurance Engineer (ISO 13485)

Prismatik

Irvine, CA • On-site, Remote

$99K - $120K/yr

Full-time

Posted 10 days ago

Job description

We're looking for a Sr. QA Engineer to help build quality into every stage of our medical device development and manufacturing. You'll have broad ownership across quality engineering, risk management, CAPA, validation, and our Quality Management System. Working closely with cross-functional teams, you'll solve complex quality challenges, support new products and processes, and help ensure what we build meets the highest standards for safety, performance, and compliance.

Essential Functions:
  • Ensure compliance with applicable regulatory standards, including FDA 21 CFR Part 820, ISO 13485, MDSAP, and EU MDR.
  • Lead and support CAPA investigations, non-conformance management, and root cause analysis using tools such as 8D, Fishbone, and 5 Whys.
  • Own and continuously improve elements of the Quality Management System (QMS), including document control, internal audits, supplier quality, and change control.
  • Collaborate cross-functionally with R&D, Manufacturing, and Regulatory Affairs to support design control, risk management (ISO 14971), and product development lifecycle activities.
  • Lead internal and supplier audits, and support external audits and inspections (e.g., FDA, Notified Bodies).
  • Participate in validation activities (IQ/OQ/PQ) for processes, equipment, and software used in manufacturing and quality operations.
  • Develop, monitor, and analyze quality metrics to identify trends, drive continuous improvement, and ensure effectiveness of corrective actions.
  • Provide quality engineering support to Quality Control, including guidance on inspection methods, metrology, and measurement system capability.
  • Conduct and document investigations of NCRs, complaints, and deviations, providing effective and sustainable corrective and preventive actions based on engineering analysis.
  • Lead and mentor junior engineers, fostering technical growth and reinforcing a culture of quality and compliance.
  • Integrate ISO 14971 risk management and IEC 62366 usability engineering activities within Glidewell/Prismatik processes.
  • Ensure organizational compliance with the QMS through ongoing training, education, and internal communication.
  • Collaborate with Manufacturing and Engineering to coordinate pilot production, process validations, and risk analyses for new products and processes.
  • Ensure calibration and preventive maintenance systems meet compliance and operational requirements.
  • Identify and implement process optimizations using Lean and Six Sigma methodologies to improve manufacturability, reduce risk, and enhance efficiency.
  • Identify opportunities for design or re-design of equipment, tools, and fixtures to improve manufacturing processes and product quality.
  • Perform other related duties and special projects as assigned by management.
Minimum Qualifications:
  • Bachelor's degree in Engineering, Science, or a related technical field.
  • Minimum of 5 years of experience in Quality Assurance or Quality Engineering within the medical device industry, or equivalent education and experience demonstrating comparable skills and knowledge.
  • Strong working knowledge of FDA regulations, ISO 13485, and other applicable international quality standards.
  • Hands-on experience with risk management (ISO 14971), design controls, and validation methodologies.
  • Proven analytical, problem-solving, and communication skills.
  • Proficiency in quality and statistical analysis tools such as Minitab or equivalent software.
  • Demonstrated project management experience.
  • Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Six Sigma certification, preferred.
  • Experience with combination products or Class I/II medical devices, preferred.
  • Familiarity with EU MDR and UDI regulatory requirements, preferred.
Pay range: $99,000 - $120,000/yr.
Exact compensation may vary based on skills and experience.
This role is fully onsite at our Irvine, CA campus. Remote or hybrid arrangements are not available.
Employment Type: full-time

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