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Medical Device Auditor Jobs (NOW HIRING)

BSI Group

As a Medical Device Auditor, you'll travel to medical device manufacturers across Europe, Middle East and Africa and occasionally USA. You'll help these manufacturers to improve their performance by ...

BSI Prof Serv EHS West

As a Medical Device Auditor, you'll travel to medical device manufacturers across Europe, Middle East and Africa and occasionally USA. You'll help these manufacturers to improve their performance by ...

Jobgether

This is an opportunity for an experienced medical device auditor to support the assessment of innovative health technologies and help ensure compliance with the highest regulatory standards. The role ...

BSI Group

Medical Device QMS Auditor

Concord, NC · Remote

$98K - $123K/yr

Medical Device QMS Auditor Location: Candidates must reside in one of the following states: IL, MN, WI, IN, NJ, MA, PA, OH. BSI (British Standards Institution) is the global business standards ...

Access Vascular

Senior Quality Systems Engineer

Billerica, MA · On-site

$94K - $127K/yr

... Certified Medical Device Auditor (CMDA), or equivalent is a plus Lead auditor certification (ISO 13485 or equivalent) is a plus Experience with implementing and validating eQMS platforms (e.g ...

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Medical Device Auditor information

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How much do medical device auditor jobs pay per hour?

As of Jul 22, 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 is a medical device auditor?

A medical device auditor is a professional responsible for inspecting and evaluating medical devices and related quality management systems to ensure compliance with regulatory standards such as ISO 13485 and FDA requirements. They typically review documentation, perform audits, and may hold certifications like ISO Lead Auditor to verify that manufacturing processes meet safety and quality standards.

How much does an FDA auditor get paid?

FDA auditors, who typically work in regulatory compliance for medical devices, earn a median annual salary of around $70,000 to $100,000, depending on experience, location, and certifications such as RAC or ISO auditor credentials. Salaries can vary based on the employer, industry sector, and whether the auditor is employed full-time or contractually. The role often requires knowledge of FDA regulations, quality systems, and auditing tools.

How to become a medical device auditor?

To become a medical device auditor, typically one needs a background in healthcare, engineering, or quality management, along with experience in medical device manufacturing or regulation. Certification such as ISO 13485 Lead Auditor or RABQSA/IRCA certification is often required, and strong knowledge of regulatory standards like FDA or MDR is essential. Developing skills in auditing, documentation, and compliance helps prepare for this role.

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.

How much do ISO 13485 auditors make?

ISO 13485 auditors typically earn between $60,000 and $100,000 annually, depending on experience, certification level, and geographic location. Senior auditors or those working for large organizations may earn higher salaries, and certification from recognized bodies can enhance earning potential.

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 July 2026, with employment types broken down into 89% Full Time, 7% Part Time, 2% Contract, 1% Nights, and 1% Summer. Highlights an 87% Physical, 6% Hybrid, and 7% Remote job distribution, with an average salary of $44,967 per year, or $21.6 per hour.

Japan medical device QMS 13485 auditor (relocation)

BSI Prof Serv EHS West

Concord, NC • On-site, Remote

Other

Posted 13 days ago

Job description

Great that you're thinking about a career with BSI!

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ISO 13485 QMS

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Medical Device 13485 Auditor in Japan /relocate to Japan(homebased)

We are looking for the candidate who is active searching this relocation opportunity in Japan.

As a Medical Device Auditor, you'll travel to medical device manufacturers across Europe, Middle East and Africa and occasionally USA. You'll help these manufacturers to improve their performance by assessing their ISO 13485 quality management system, so they can ensure patient safety and comply with regulatory procedures.

In the first six months of being a Medical Device Auditor you'll:

  • Be given training in ISO 13485 Lead Auditor training, MDSAP (Medical Device Single Audit Programme) and MDR (Medical Device Regulation)

  • Initially observe how audits are conducted but then grow to conduct them on an individual basis on site at medical device manufacturers across EMEA and remotely from your home office.

In a typical week after being fully trained you'll:

  • Conduct an audit on site or remotely

  • Write up your reports and liaise with the planning team to manage your audit schedule.

  • You'll also continue your development of MDR and be an advocate for the ISO 13485 EMEA Delivery Team.

To thrive in this career, you must:

  • Have 4 years or more being directly accountable for the design or test or manufacture of different medical devices.

  • Be degree educated with discipline relevant to Medical Devices e.g. chemistry, physical chemistry, molecular genetics, textiles, material science, biology, biotechnology or similar.

  • Have at least 2 years' experience working in an environment with a Quality Management System established.

  • Be able to speak and write fluently in the Japanese and English language.

  • Be resilient and able to meet audit delivery by travelling frequently across the EMEA region as required

We're enthusiastic to receive applications from those based in Japan/ relocate to Japan excited by this career opportunity.

#LI-VW

Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.

BSI is an Equal Opportunity Employer and we are committed to diversity.

BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.

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