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Remote Iso 13485 Auditor Jobs (NOW HIRING)

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 ...

Getinge

Internal Auditor Corporate Quality

Nashua, NH · Remote

Evidence of training to QSmR, ISO 13485:2016, EU MDR, MDSAP and ISO 9001:2015 * Valid passport and ... LI-Remote About us With a firm belief that every person and community should have access to the ...

Medline

Manager Quality Assurance, Audit

Broad technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971 ... Experience in Auditing for Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products ...

Medline

Manager Quality Internal Audit QMS

Broad technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971 ... Experience in Auditing for Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products ...

Creation

Senior Global Regulatory Manager

The role will provide leadership across areas such as ISO 9001, ISO 13485, AS9100, ISO 27001/27002, global auditing, risk management, regulatory governance, customer requirements, quality agreements ...

New

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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 21, 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 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 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 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.

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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 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.

Quality Auditor - Pharmaceutical

SQA Services

Carmel, IN • Remote

$1.3K/day

Full-time

Re-posted 23 hours 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 the Midwest. 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, and Canada GMP
  • 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, ISO 13485, 21 CFR 100, and/or 21 CFR 507
  • 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 and identifying potential inconsistencies or verification signals in application materials based on available information. 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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