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Remote 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 ...

Scarlet

Lead Auditor - Contractor role

Conduct remote audits of medical device manufacturers' Quality Management Systems under ISO 13485 ... Auditing experience * Prior work with notified bodies or accreditation bodies as a Lead Auditor

BSI Group

Medical Device QMS Auditor

Concord, NC · Remote

$98K - $123K/yr

BSI is an accredited ISO 13485 Certification Body recognized in many global markets. This is a ... LI-REMOTE #LI-MS1 About Us BSI is a business improvement and standards company and for over a ...

SQA Services

Quality Auditor - Pharmaceutical

Chicago, IL · Remote

$1.3K/day

... remote surveillance, corrective actions, remediation, inspections, and engineering solutions to ... Direct audit experience to ISO 17025, ISO 15378, IPEC GDP, ICH Q7, ISO 13485, 21 CFR 100, and/or 21 ...

SQA Services

Quality Auditor - Pharmaceutical

Warren, IN · Remote

$1.3K/day

... remote surveillance, corrective actions, remediation, inspections, and engineering solutions to ... Direct audit experience to ISO 17025, ISO 15378, IPEC GDP, ICH Q7, ISO 13485, 21 CFR 100, and/or 21 ...

SQA Services

Quality Auditor - Pharmaceutical

Carmel, IN · Remote

$1.3K/day

... remote surveillance, corrective actions, remediation, inspections, and engineering solutions to ... Direct audit experience to ISO 17025, ISO 15378, IPEC GDP, ICH Q7, ISO 13485, 21 CFR 100, and/or 21 ...

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Remote Iso 13485 Auditor information

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How much do remote iso 13485 auditor jobs pay per hour?

As of Aug 3, 2026, the average hourly pay for remote 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 are the key skills and qualifications needed to thrive as a remote ISO 13485 auditor?

To thrive as a Remote ISO 13485 Auditor, you need deep knowledge of quality management systems, medical device regulations, and auditing principles, typically supported by ISO 13485 Lead Auditor certification and relevant industry experience. Familiarity with audit management software, document control systems, and virtual collaboration tools is essential for conducting remote audits effectively. Strong attention to detail, critical thinking, and clear communication are vital soft skills for evaluating compliance and interacting with clients. These skills ensure thorough, accurate audits and help maintain high-quality standards in the medical device industry.

What are some unique challenges faced by remote ISO 13485 auditors compared to on-site auditors?

Remote ISO 13485 Auditors often encounter challenges related to communication and document access, as they must rely on digital platforms to review procedures and conduct interviews with auditees. It can be more difficult to observe processes in real time and verify compliance without being physically present at the site. To overcome these challenges, auditors use video conferencing tools, secure file-sharing systems, and detailed planning to ensure thorough audits. Collaboration with the client's quality and compliance teams is crucial to ensure all necessary documents and evidence are accessible remotely.

What is a remote ISO 13485 auditor?

A Remote ISO 13485 Auditor is a professional who evaluates and verifies a company's quality management system for medical devices according to the ISO 13485 standard, but does so virtually using digital tools rather than on-site visits. They review documents, conduct interviews, and assess compliance with regulatory requirements through video calls, shared documents, and other online platforms. This role is crucial for ensuring that manufacturers maintain high standards for safety and quality in medical devices, especially when in-person audits are not feasible.

What is the difference between Remote Iso 13485 Auditor vs Remote Quality Assurance Specialist?

AspectRemote Iso 13485 AuditorRemote Quality Assurance Specialist
CertificationsISO 13485 Auditor Certification, CQE or equivalentISO 13485 Certification, CQE or similar
Work EnvironmentAuditing medical device companies, compliance assessmentsDeveloping and maintaining quality systems, process improvements
Industry UsageMedical device manufacturing, regulatory complianceMedical device, healthcare, and manufacturing sectors

The Remote Iso 13485 Auditor primarily conducts compliance audits of medical device companies to ensure adherence to ISO 13485 standards. In contrast, the Remote Quality Assurance Specialist focuses on developing quality processes and supporting ongoing compliance. Both roles require similar certifications and work within the medical device industry, but their core responsibilities differ: auditing versus quality system management.

More about Remote Iso 13485 Auditor jobs
What cities are hiring for Remote Iso 13485 Auditor jobs? Cities with the most Remote Iso 13485 Auditor job openings:
What are the most commonly searched types of Iso 13485 Auditor jobs? The most popular types of Iso 13485 Auditor jobs are:
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Remote Iso 13485 Auditor jobs near you
Infographic showing various Remote Iso 13485 Auditor job openings in the United States as of July 2026, with employment types broken down into 7% Locum Tenens, 86% Full Time, 1% Part Time, 1% Temporary, 4% Contract, and 1% Nights. Highlights an 93% Physical, 2% Hybrid, and 5% 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

Other

Re-posted 20 days ago

Job description

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

ISO
18081,000
1901ISO90
ISO 13485 QMS

（MUST）


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＊

（）

＊

（）

（WANT）


/


＊ＢＳＩ

：（）

＊ISO13485


：9：00～17：30（60）


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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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