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Certified Medical Device Auditor Jobs (NOW HIRING)

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 ...

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 ...

SGS

Contract Opportunity - Medical Device Auditors

ISO 9001 qualification As a Contract Medical Device Auditor, you will perform third-party audits per SGS Certification procedures and the requirements for standards such as ISO 13485, MDSAP, MDD and ...

DQS

Contract Medical Device Lead Auditor

Schaumburg, IL ยท On-site

Your role Medical Device Lead Auditor DQS Inc. has an immediate contract opportunity for a Medical Device Lead Auditor. Working closely with your schedulers, you will visit client locations and ...

BSI Group

Medical Device QMS Auditor

Concord, NC ยท Remote

$98K - $123K/yr

Job Title: Medical Device QMS Auditor Location: Candidates must reside in one of the following ... BSI is an accredited ISO 13485 Certification Body recognized in many global markets. This is a ...

Hearst Health

Medical Device Coder

Carmel, IN ยท On-site

$18.50 - $24.75/hr

Experience assigning or auditing HCPCS Level II code sections, including A-codes, C-codes, or E ... Active coding certification from AAPC or AHIMA. Relevant credentials include: Certified ...

Hearst

Medical Coder Specialist

Carmel, IN ยท On-site

Experience assigning or auditing HCPCS Level II code sections, including A-codes, C-codes, or E ... medical device industry preferred. * Active coding certification from AAPC or AHIMA. Relevant ...

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Certified Medical Device Auditor information

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$64.5K

$87K

$97.5K

How much do certified medical device auditor jobs pay per year?

As of Aug 29, 2026, the average yearly pay for certified medical device auditor in the United States is $86,952.00, according to ZipRecruiter salary data. Most workers in this role earn between $84,000.00 and $92,500.00 per year, depending on experience, location, and employer.

What is a certified medical device auditor?

A Certified Medical Device Auditor is a professional who has been trained and certified to assess the quality management systems of organizations that design, manufacture, or distribute medical devices. Their primary role is to ensure that these organizations comply with applicable regulations and standards, such as ISO 13485 or FDA requirements. Certified Medical Device Auditors conduct audits, review documentation, and recommend improvements to help organizations maintain compliance and enhance product safety. They often work for regulatory bodies, certification organizations, or as independent consultants.

What are the key skills and qualifications needed to thrive as a certified medical device auditor, and why are they important?

To thrive as a Certified Medical Device Auditor, you need strong knowledge of medical device regulations, quality management systems (like ISO 13485), and auditing principles, usually supported by relevant certifications such as ASQ CQA or ISO 13485 Lead Auditor. Proficiency with audit management software, document control systems, and regulatory databases is typically required. Outstanding attention to detail, analytical thinking, and effective communication skills set top auditors apart. These skills ensure compliance, product safety, and continuous improvement in a highly regulated industry.

What are some typical challenges faced by certified medical device auditors during audits, and how can they be addressed?

Certified Medical Device Auditors often encounter challenges such as interpreting complex regulatory requirements, managing documentation inconsistencies, and ensuring effective communication between cross-functional teams. To address these challenges, auditors should stay updated on current regulations (like ISO 13485 or FDA 21 CFR Part 820), maintain strong organizational skills, and foster collaborative relationships with quality assurance, engineering, and manufacturing teams. Proactive preparation and continuous professional development can help auditors navigate these complexities and ensure thorough, compliant audits.

What is the difference between Certified Medical Device Auditor vs Medical Device Quality Inspector?

AspectCertified Medical Device AuditorMedical Device Quality Inspector
CertificationsISO 13485 Lead Auditor, Certified Medical Device AuditorISO 13485 Internal Auditor, Quality Inspection Certifications
Work EnvironmentAuditing compliance, conducting assessments, documentation reviewInspecting devices, quality checks, ensuring manufacturing standards
Employer & IndustryMedical device companies, certification bodies, regulatory agenciesManufacturers, quality assurance departments, inspection firms

The Certified Medical Device Auditor focuses on auditing and ensuring compliance with industry standards, while the Medical Device Quality Inspector performs hands-on inspections during manufacturing. Both roles are essential for maintaining product quality but differ in scope and responsibilities.

More about Certified Medical Device Auditor jobs

What states have the most Certified Medical Device Auditor jobs?

States with the most job openings for Certified Medical Device Auditor jobs include:

What job categories do people searching Certified Medical Device Auditor jobs look for?

The top searched job categories for Certified Medical Device Auditor jobs are:

Certified Medical Device Auditor jobs near you
Infographic showing various Certified Medical Device Auditor job openings in the United States as of August 2026, with employment types broken down into 68% Full Time, 9% Part Time, 5% Temporary, and 18% Contract. Highlights an 86% In-person, 5% Hybrid, and 9% Remote job distribution, with an average salary of $86,952 per year, or $41.8 per hour.

Japan medical device QMS 13485 auditor (relocation)

Concord, NC โ€ข On-site, Remote

BSI Prof Serv EHS West
See more jobs at BSI Prof Serv EHS Westexternal

Full-time

Re-posted 21 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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