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How much do medical device auditor jobs pay per hour?

As of Jun 9, 2026, the average hourly pay for medical device auditor in the United States is $21.62, according to ZipRecruiter salary data. Most workers in this role earn between $17.31 and $27.40 per hour, depending on experience, location, and employer.

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

To excel as a Medical Device Auditor, you need a solid background in quality management systems, regulatory compliance, and a relevant science or engineering degree. Familiarity with ISO 13485, FDA regulations, and audit management software is highly valued, as are certifications such as Lead Auditor or RABQSA/IRCA credentials. Strong analytical skills, attention to detail, and the ability to communicate findings diplomatically are key soft skills for the position. These abilities ensure audits are thorough, regulatory requirements are met, and issues are effectively communicated to drive continuous improvement in medical device manufacturing.

What is a Medical Device Auditor job?

A Medical Device Auditor is responsible for evaluating medical device manufacturers to ensure compliance with regulatory standards such as ISO 13485, FDA regulations, and EU MDR. They conduct audits, review documentation, and assess quality management systems to verify that products meet safety and performance requirements. Their role helps ensure that medical devices are safe for patient use and meet industry standards. Auditors may work independently or for regulatory bodies, certification organizations, or manufacturers. Strong knowledge of regulatory frameworks and auditing techniques is essential for this role.

What does a typical workweek look like for a Medical Device Auditor?

A typical workweek for a Medical Device Auditor often involves a combination of preparing audit materials, conducting on-site or remote audits, reviewing technical documentation, and writing comprehensive audit reports. Depending on the employer, you may travel to manufacturing sites or interact virtually with client teams to assess compliance with regulatory standards. Collaboration with quality assurance teams, engineers, and regulatory affairs professionals is common, as you help organizations identify and address potential gaps in their quality systems. This role offers a dynamic environment and the opportunity to stay updated with evolving industry regulations, making each week varied and engaging.

More about Medical Device Auditor jobs
What cities are hiring for Medical Device Auditor jobs? Cities with the most Medical Device Auditor job openings:
What are the most commonly searched types of Medical Device Auditor jobs? The most popular types of Medical Device Auditor jobs are:
What states have the most Medical Device Auditor jobs? States with the most job openings for Medical Device Auditor jobs include:
What job categories do people searching Medical Device Auditor jobs look for? The top searched job categories for Medical Device Auditor jobs are:
Medical Device Auditor jobs near you
Infographic showing various Medical Device Auditor job openings in the United States as of June 2026, with employment types broken down into 83% Full Time, and 17% Part Time. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution, with an average salary of $44,967 per year, or $21.6 per hour.
Quality Auditor - Pharmaceutical/Medical Device

Quality Auditor - Pharmaceutical/Medical Device

SQA Services

Minneapolis, MN • Remote

$1K/day

Other

Posted 28 days ago

Job description

For nearly 30 years, SQA Services has been a leading provider of managed supplier quality services, offering audits, assessments, remote surveillance, corrective actions, remediation, inspections, and engineering solutions to manufacturers across all industries. We deliver these services by deploying a network of highly skilled associates based throughout the United States and in over 90 countries worldwide, ensuring rapid on-site support at your supplier locations. Our associates are expert quality assurance professionals with extensive experience and local expertise, enabling us to represent our clients on-demand and with greater speed and efficiency than our competitors.
 
We're hiring a Pharma Quality Auditor. This is a contract opportunity in which you will perform supplier quality  audits at various suppliers in Japan. These audits are generally 1-2 days long. You are given the flexibility to accept or reject these assignments according to your own availability. 
Key Responsibilities
  • Perform supplier audits at various sites within your region of residence
  • Assure quality in the supply chains of various clients within the pharmaceutical, medical device, cosmetics, biologics, and/or animal health industries
  • Coordinate, prepare, execute, and deliver supplier audits based on your own and the client schedule
  • Utilize your regulatory knowledge of various standards from ISO, CFR, FDA, etc...
  • Respond to the Content team in a timely manner regarding edits/questions to your audit report
  • Write audit reports in accordance with client specifications
Required Qualifications
  • 5+ years of hands-on audit experience in pharmaceutical, medical device, and/or biologics industries
  • Has been the lead auditor in at least 10 audits
  • Direct audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820
  • Strong communication and writing skills
  • Proven ability to deescalate workplace conflicts effectively
  • Ability to adapt to new technology and software.
  • Willingness to travel regionally
Preferred Qualifications
  • Direct audit experience to ISO 17025, ISO 15378, IPEC GDP, ICH Q7 and/or Canada GMP
  • ISO certifications are a plus but not mandatory
$1,300 - $1,300 a day
Pay Rate: 
 
$1300 for a 1-day audit. Includes: Time spent preparing for the audit, traveling, performing the audit, writing the report, and responding to questions from our Content team of editors and the client until the report is finalized. Does not include: Following up on CAPA for any findings or reimbursement for travel expenses - expenses are reimbursed at cost with receipts per SQA travel policy. Note that SQA helps with the preparation of the audit and proofreads all audit reports.
 
Note: SQA is an Equal Opportunity Employer. Employment is based on merit and qualifications, and is not influenced by race, color, religion, gender, national origin, veteran status, disability, age, sexual orientation, gender identity, marital status, or any other legally protected status.
 
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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.
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