ZipRecruiter

Log In

1

Fda Auditor Jobs (NOW HIRING)

Boston Scientific

Senior QA Auditor

Santa Clarita, CA · On-site

... the FDA and notified bodies. The position requires deep knowledge of quality systems within the ... ISO 13485 Lead Auditor certification is required. * Minimum of five (5) years of experience in the ...

Intertek

Food Safety Auditor-Full Time

Boxborough, MA

Food Safety Auditor - United States - Remote This is a remote position with 85% travel; applicants ... Knowledge of USDA/FDA regulations * Certificate in HACCP Implementation or PCQI * Knowledge of GFSI ...

Boston Scientific

Senior QA Auditor

Santa Clarita, CA · On-site

... the FDA and notified bodies. The position requires deep knowledge of quality systems within the ... ISO 13485 Lead Auditor certification is required. * Minimum of five (5) years of experience in the ...

Abbott

Senior Quality Auditor

Lake Forest, IL · On-site

The Quality Auditor shall also be responsible for performing third party supplier audits for ... FDA, and other regulatory agencies. * Responsible for exhibiting professional behavior with both ...

Abbott

Senior Quality Auditor

Lake Forest, IL

The Quality Auditor shall also be responsible for performing thirdparty supplier audits for ... FDA, and other regulatory agencies. * Responsible for exhibiting professional behavior with both ...

Abbott

Senior Quality Auditor

Lake Forest, IL · On-site

The Quality Auditor shall also be responsible for performing thirdparty supplier audits for ... FDA, and other regulatory agencies. * Responsible for exhibiting professional behavior with both ...

Frontage Laboratories

QA Specialist/Auditor

Chicago, IL · On-site

$65K - $75K/yr

QA Specialist/Auditor Title: QA Specialist/Auditor Location: Chicago, IL Reports to : Senior ... GLP (FDA, EPA, OECD and JMHW) regulations, Study Protocol, and Company's SOPs. * Audit study ...

Elanco

Global Quality Auditor Lead

Indianapolis, IN · Hybrid

Demonstrated success in auditing aseptic or sterile manufacturing platforms under FDA, EMA, or similar regulatory oversight * Experience leading or contributing to quality improvement initiatives ...

Agilent

... FDA cGMP/QSR, EU GMP, IVDR, and ICH requirements. Develop audit strategies, plans, and reports ... Experience auditing across the full product lifecycle, including design, manufacturing ...

Merican

GCP Auditor, Quality Assurance

Paramus, NJ · On-site

Job Title: GCP Auditor, Quality Assurance Location: Paramus, NJ, 07652 Job Type: Temporary ... FDA regs, GCP, etc.). * Collaborate with clinical sourcing, supplier quality and clinical ...

IQVIA

Sr. Clinical QA Auditor

Washington, DC · Remote

$75K - $188K/yr

Overview The Sr. Clinical QA Auditor is a critical CQA team member. We are seeking an experienced ... Design and lead mock FDA/EMA inspections and inspection readiness initiatives for sponsors and ...

IQVIA

Sr. Clinical QA Auditor

Washington, DC · Remote

$75K - $188K/yr

Overview The Sr. Clinical QA Auditor is a critical CQA team member. We are seeking an experienced ... Design and lead mock FDA/EMA inspections and inspection readiness initiatives for sponsors and ...

next page

Showing results 1-20

All JobsFda Auditor Jobs

Fda Auditor information

See salary details

$33K

$76.3K

$121.5K

How much do fda auditor jobs pay per year?

As of Jun 9, 2026, the average yearly pay for fda auditor in the United States is $76,256.00, according to ZipRecruiter salary data. Most workers in this role earn between $53,500.00 and $98,500.00 per year, depending on experience, location, and employer.

What is an FDA Auditor job?

An FDA Auditor is responsible for inspecting facilities, processes, and documentation to ensure compliance with U.S. Food and Drug Administration (FDA) regulations. They review manufacturing practices, quality control systems, and regulatory filings for industries such as pharmaceuticals, medical devices, and food production. FDA Auditors may work for the FDA or for companies preparing for FDA inspections. Their role helps ensure public safety by verifying that products meet legal and quality standards.

What are the key skills and qualifications needed to thrive in the Fda Auditor position, and why are they important?

To thrive as an FDA Auditor, you need a strong background in life sciences, regulatory compliance, and audit methodologies, usually supported by a relevant degree and professional certifications such as RAC or CQA. Familiarity with FDA regulations (such as 21 CFR), electronic quality management systems (eQMS), and audit management tools is essential. Attention to detail, critical thinking, and strong communication skills help auditors navigate complex regulatory settings and interact effectively with stakeholders. These competencies are crucial for ensuring companies meet rigorous FDA standards and maintain regulatory compliance.

What are the primary challenges FDA Auditors face during compliance inspections?

FDA Auditors often encounter challenges such as interpreting complex and evolving regulatory guidelines, managing on-site audits in diverse environments, and reviewing extensive documentation under tight timeframes. They must adapt quickly to various industry settings, handle potentially uncooperative stakeholders, and maintain objectivity throughout their evaluations. Successfully overcoming these challenges requires resilience, up-to-date regulatory knowledge, and excellent people skills. These hurdles are a vital part of ensuring public health and safety by holding organizations to the highest standards of compliance.

More about Fda Auditor jobs
What cities are hiring for Fda Auditor jobs? Cities with the most Fda Auditor job openings:
What are the most commonly searched types of Fda Auditor jobs? The most popular types of Fda Auditor jobs are:
What states have the most Fda Auditor jobs? States with the most job openings for Fda Auditor jobs include:
What job categories do people searching Fda Auditor jobs look for? The top searched job categories for Fda Auditor jobs are:
Fda Auditor jobs near you
Infographic showing various Fda Auditor job openings in the United States as of June 2026, with employment types broken down into 89% Full Time, and 11% Nights. Highlights an 100% In-person job distribution, with an average salary of $76,256 per year, or $36.7 per hour.
Senior QA Auditor

Senior QA Auditor

Boston Scientific

Santa Clarita, CA • On-site

Full-time

Posted 26 days ago

Boston Scientific rating

8.5

Company rating: 8.5 out of 10

Based on 119 frontline employees who took The Breakroom Quiz

33rd of 516 rated manufacturers

Job description

Recruiter: Spencer Gregory Hale
Senior QA Auditor
About the role:
This Senior QA Auditor role focuses on planning, executing, and documenting internal and external quality audits, with a strong emphasis on ISO 13485 compliance. The individual will lead audits end to end-developing audit plans, conducting on-site and system audits, writing clear and detailed audit reports and findings, and following through on corrective actions-while also supporting and managing external audits with regulatory bodies such as the FDA and notified bodies. The position requires deep knowledge of quality systems within the medical device or pharmaceutical industry, strong critical thinking and questioning skills to drive process improvement, excellent written and verbal communication, and the ability to work cross-functionally, collaborate effectively, and provide clear updates to management.
Your responsibilities will include:
  • Audit Planning & Execution - Develop and execute annual audit plans covering the landscape of the Quality Systems applicable to the division.
  • Compliance Monitoring: Ensure adherence to internal policies, external standards, and regulations.
  • Evaluate the adequacy and compliance of systems, operations, and practices against regulations and company documentation.
  • Assess the effectiveness of internal controls, risk management systems, and identify vulnerabilities in the processes and sub-processes within the Quality Systems.
  • Formulate and document nonconformities and obtain concurrence from responsible management.
  • Track issues through to closure, including reviewing the corrective actions taken.
  • Develop audit plans, including scope and objectives, and obtain management approval.
  • Communicate the results of audits to responsible management through the appropriate channels.
  • Prepare clear reports on findings, obtain approval, and publish results to the responsible management.
  • Oversee the follow-up of corrective actions and audit closure, including escalating overdue items as necessary.
  • Participate and support external investigators/auditors from regulatory authorities and notified bodies.

What we're looking for in you:
Required Qualifications:
  • Bachelor's degrees at a minimum.
  • ISO 13485 Lead Auditor certification is required.
  • Minimum of five (5) years of experience in the medical device or pharmaceutical industry, specifically within quality systems.
  • Senior-level experience in quality auditing, with the ability to independently plan, execute, and close audits.
  • Demonstrated experience conducting internal audits and supporting or managing external audits, including audits with regulatory bodies and notified bodies (e.g., FDA, TÜV).
  • Strong working knowledge of quality systems and ISO 13485 requirements.
  • Excellent written communication skills, with experience writing audit reports, findings, and documentation.
  • Strong verbal communication and questioning skills, with the ability to critically assess processes and drive improvement.
  • Proven ability to work cross-functionally, collaborate effectively with stakeholders, and provide updates to management.

Preferred qualifications:
  • Previous Boston Scientific experience
  • Proven project management experience

Requisition ID: 628992
Minimum Salary: $ 89200
Maximum Salary: $ 169500
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

What Boston Scientific employees say

Pay

Benefits

Hours and flexibility

Workplace

Get the full story on Breakroom

Apply