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Iso 13485 Auditor Jobs (NOW HIRING)

BSI Group

ISO 18081,000 1901ISO90 ISO 13485 QMS （MUST） （） ＊ （） ＊ （） （WANT） ... As a Medical Device Auditor, you'll travel to medical device manufacturers across Europe, Middle ...

BSI Prof Serv EHS West

ISO 18081,000 1901ISO90 ISO 13485 QMS （MUST） （） ＊ （） ＊ （） （WANT） ... As a Medical Device Auditor, you'll travel to medical device manufacturers across Europe, Middle ...

UpDoc, Inc.

$110 - $170/hr

ISO 13485 Auditor certification * Experience with Software as a Medical Device (IEC 62304, IEC 82304) * Experience in early-stage or high-growth startups, building QMS process from scratch

New

DQS

Contract Medical Device Lead Auditor

Schaumburg, IL · On-site

Experience with internal, 2nd or 3rd party ISO-9001, ISO 13485, and/ or GMP auditing. * Preference given to RAB-QSA or Exemplar Global Lead Auditor or Auditor qualification. * Ability to develop an ...

DQS

Contract Medical Device Lead Auditor

Schaumburg, IL · On-site

Experience with internal, 2nd or 3rd party ISO-9001, ISO 13485, and/ or GMP auditing. * Preference given to RAB-QSA or Exemplar Global Lead Auditor or Auditor qualification. * Ability to develop an ...

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How much do iso 13485 auditor jobs pay per hour?

As of Aug 20, 2026, the average hourly pay for iso 13485 auditor in the United States is $19.21, according to ZipRecruiter salary data. Most workers in this role earn between $14.42 and $19.23 per hour, depending on experience, location, and employer.

What is an ISO 13485 auditor?

ISO 13485 Auditors are professionals responsible for evaluating whether a company’s quality management systems for medical devices comply with the ISO 13485 standard. They conduct thorough audits to assess documentation, processes, and compliance with regulatory requirements. Their work ensures that organizations maintain high standards for the safety and effectiveness of medical devices. Auditors may work internally within an organization or externally as part of a certification body. Their findings help companies identify areas for improvement and maintain certification.

What are the key skills and qualifications needed to thrive as an ISO 13485 auditor?

To thrive as an ISO 13485 Auditor, you need expertise in quality management systems, extensive knowledge of medical device regulations, and typically a background in engineering or life sciences, often supported by ISO 13485 Lead Auditor certification. Familiarity with auditing tools, document control systems, and regulatory compliance software is essential. Strong attention to detail, analytical thinking, and effective communication skills help auditors assess processes and interact with clients. These competencies ensure accurate evaluations, regulatory compliance, and the continual improvement of medical device quality management systems.

What are some common challenges ISO 13485 auditors face during audits and how can they be addressed?

ISO 13485 Auditors often encounter challenges such as incomplete documentation, resistance from staff, or inconsistent implementation of quality management processes. To address these, auditors should foster open communication, clarify audit objectives, and provide clear guidance on documentation requirements. Building rapport with auditees and staying updated on regulatory changes also helps ensure smoother audits and continuous improvement within the organization.

What is the difference between Iso 13485 Auditor vs ISO 13485 Quality Inspector?

AspectIso 13485 AuditorISO 13485 Quality Inspector
CertificationsISO 13485 Auditor CertificationTypically no specific certification, but may have quality inspection training
Work EnvironmentAudits multiple facilities, assesses compliance, often in office or on-sitePerforms inspections on manufacturing lines or products, primarily on-site
Employer & IndustryMedical device companies, certification bodies, consulting firmsMedical device manufacturing companies, quality assurance teams

While both roles focus on quality in the medical device industry, an Iso 13485 Auditor conducts comprehensive audits to ensure compliance with ISO 13485 standards, often across multiple sites. In contrast, an ISO 13485 Quality Inspector performs hands-on inspections of products or processes to verify quality at specific points. The auditor's role is more evaluative and documentation-focused, whereas the inspector's role is more about real-time quality verification.

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Iso 13485 Auditor jobs near you
Infographic showing various Iso 13485 Auditor job openings in the United States as of August 2026, with employment types broken down into 91% Full Time, 2% Part Time, 5% Contract, and 2% Nights. Highlights an 89% Physical, 4% Hybrid, and 7% Remote job distribution, with an average salary of $39,947 per year, or $19.2 per hour.

Japan medical device QMS 13485 auditor (relocation)

BSI Group

On-site, Remote

Full-time

Re-posted 6 days ago

Job description

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

ISO
18081,000
1901ISO90
ISO 13485 QMS

（MUST）


（）

＊

（）

＊

（）

（WANT）


/


＊ＢＳＩ

：（）

＊ISO13485


：9：00～17：30（60）


：14（）

：

：（1）（60）

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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