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Medical Device Auditor Jobs (NOW HIRING)

Apple

Senior Lead Auditor - Medical Devices

Cupertino, CA · On-site

$99K - $122K/yr

Description The Health group is looking for a Senior Lead Auditor to support regulated medical device features. If you are passionate about the health space and want to have an incredible impact here ...

Nova Biomedical

Senior Quality Engineer

Billerica, MA

$94K - $127K/yr

ASQ Certification as Medical Device Auditor is a plus. * ASQ Certification as Quality Engineer is preferred. Physical Requirements and Working Conditions: * Ability to stand, walk, and move for ...

Scarlet

Lead Auditor - Contractor role

About the role Scarlet's Quality Team ensures that innovative medical device companies meet the ... We're expanding our auditor pool and are looking for part-time/contractor lead auditors who can ...

Collabera

Auditor

Mundelein, IL · On-site

$28 - $30/hr

Must Haves: 3+ years of Quality Assurance or Quality Auditing experience within the medical device, pharmaceutical, or healthcare industry Hands-on experience conducting quality audits of regulated ...

Nova Biomedical

Senior Quality Engineer

Billerica, MA

$94K - $127K/yr

ASQ Certification as Medical Device Auditor is a plus. * ASQ Certification as Quality Engineer is preferred. Physical Requirements and Working Conditions: * Ability to stand, walk, and move for ...

Nova Biomedical

Senior Quality Engineer

Billerica, MA · On-site

$94K - $127K/yr

ASQ Certification as Medical Device Auditor is a plus. * ASQ Certification as Quality Engineer is preferred. Physical Requirements and Working Conditions: * Ability to stand, walk, and move for ...

Collabera

Quality Auditor

Mundelein, IL · On-site

$25 - $30/hr

Title - Quality Auditor | Auditor Location - Mundelein, IL, 60060 Duration - 06 Months Pay Rate ... the medical device, pharmaceutical, or healthcare industry Strong understanding of FDA Quality ...

Teleflex

Quality Auditor

Morrisville, NC · On-site

Position Summary Teleflex is seeking a Quality Auditor to join our Strategic Compliance department ... Medical Device Regulations TG(MD)R: Therapeutic Goods (Medical Devices) Regulations 2002 ANVISA RDC ...

Sotera Health

Quality Auditor I

Nelson, NE

... medical device companies and 9 of the top 10 pharmaceutical companies. Job summary: The Quality ... The auditor provides regulatory and policy and procedural guidance. The auditor collaborates with ...

Teleflex

Quality Auditor

Morrisville, NC · On-site

Position Summary Teleflex is seeking a Quality Auditor to join our Strategic Compliance department ... Medical Device Regulations • TG(MD)R: Therapeutic Goods (Medical Devices) Regulations 2002 • ...

Clark Davis Associates

Senior IT Auditor

Mahwah, NJ

$94K - $124K/yr

Company Description Medical device manufacturer located in Bergen County, NJ Medical device manufacturer located in Bergen County, NJ is seeking a qualified Senior IT Auditor. Responsibilities ...

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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 25, 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.

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What cities are hiring for Medical Device Auditor jobs? Cities with the most Medical Device Auditor job openings:
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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.
Quality Analyst/EU Auditor

Quality Analyst/EU Auditor

Siri InfoSolutions Inc

Austin, TX • On-site

Contractor

Posted 7 days ago

Job description

Job Title : European Union Medical Device Regulation Auditor

Location: Austin, TX

Duration: 6 months

Key Responsibilities:

  • Plan, scope, and lead comprehensive mock audits to assess readiness for an upcoming BSI notified body audit.
  • Evaluate the medical device manufacturer’s Quality Management System (QMS) against ISO 13485:2016 and the EU MDR 2017/745.
  • Conduct rigorous onsite or virtual stress-testing of core QMS processes:
  • Management Responsibility & Resource Management
  • Design and Development / Technical Documentation Files
  • Production and Service Provision (Cleanroom, Sterilization, Validation)
  • CAPA, Complaint Handling, and Post-Market Surveillance (PMS)
  • Review Technical Files and Design History Files (DHF) to ensure alignment with BSI expectations.
  • Prepare detailed mock audit reports, classifying findings into Major and Minor nonconformances using Notified Body criteria.
  • Provide a definitive gap analysis report outlining critical vulnerabilities and immediate remediation strategies.
  • Debrief leadership and process owners on audit outcomes, providing actionable guidance on how to interface with BSI auditors.
  • Assess the readiness of subject matter experts (SMEs) through simulated front-room/back-room interview dynamics.

Required Qualifications:

  • Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
  • Minimum 8 years of experience in the Medical Device industry, specifically in Quality Assurance or Regulatory Affairs.
  • Certified ISO 13485 Lead Auditor (IRCA, Exemplar Global, or equivalent).
  • Proven track record of preparing medical device manufacturers for successful Notified Body audits, specifically with BSI.
  • Deep, current knowledge of ISO 13485:2016, ISO 14971 (Risk Management), and European medical device regulations.
  • Strong analytical, interviewing, and technical report-writing skills.
  • Ability to deliver objective, critical feedback constructively under tight preparation timelines.

Preferred Qualifications:

  • Former BSI Lead Auditor experience is highly preferred.
  • Hands-on experience managing a front-room/back-room during a live BSI QMS audit.
  • Experience auditing the specific device risk classification and technology relevant to our product portfolio.
  • Familiarity with MDSAP requirements.

Key Competencies:

  • BSI Audit Readiness & Notified Body Interface
  • Rigorous Gap Analysis & Nonconformance Classification
  • Risk-Based Auditing & Technical File Evaluation
  • SME Coaching & Interview Preparation
  • Objective, High-Pressure Stakeholder Communication
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About Siri Infosolutions

Sourced by ZipRecruiter

Our team of experts first gather each and every requirement of yours. Our research and development team then sit around those requirements and come up with a plan. Our implementation team then executes that plan for optimal results. After that our support team remains in constant touch with you during and after the entire process.

Industry

It services

Company size

201 - 500 Employees

Headquarters location

Edison, NJ, US

Year founded

2005

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