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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 ...

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 ...

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: * Able to stand, walk, and move for extended ...

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: * Able to stand, walk, and move for extended ...

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Medical Device Auditor information

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How much do medical device auditor jobs pay per hour?

As of Sep 2, 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 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 are the key skills and qualifications needed to thrive as a medical device auditor?

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.

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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Medical Device Auditor jobs near you
Infographic showing various Medical Device Auditor job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 92% Physical, 1% Hybrid, and 7% Remote job distribution, with an average salary of $44,967 per year, or $21.6 per hour.

Medical Device Audit Inspector

Astura Medical

Irving, TX • On-site

$20 - $21/hr

Full-time

Re-posted 20 days ago

Job description

Description:

As a Medical Device Audit Inspector, you will support various inventory activities within the company. In this role, you are responsible for inspecting and auditing/quality control of surgical instruments, researching discrepancies of inventory within the surgical kits using SAP. This is a high-energy, deadline-driven, and collaborative team that works together to meet daily deadlines to ship products. This position works from the direction of the Receiving Manager to process inventory. Your work ensures that only safe, functional instruments are reprocessed and redistributed, directly impacting patient safety and surgical outcomes.


  • Work Schedule is Monday – Friday, 10:00 AM - 7:00 PM
  • Audit returned surgical instruments for damage, missing components, functionality, or contamination
  • Creating nonconforming and discrepancy reports using ERP software
  • Cleaning of incoming surgical instruments
  • Inspection of surgical instruments
  • Receiving inventory and data input into SAP system


Requirements:
  • 1+ years of experience auditing or inspecting medical instruments preferred
  • Familiarity with medical device handling, sterilization, or reprocessing workflows
  • Strong attention to detail and documentation skills
  • Experience with SAP or similar ERP systems
  • Excellent computer skills; Windows, MS Excel, MS Word
  • Excellent communication and organizational abilities


Physical Requirements

  • This position requires the ability to lift and carry boxes weighing up to 50 pounds on occasion
  • Must be able to stand, bend, and walk for extended periods of time
  • Must be able to reach, bend, push, lift, and climb continuously
  • Reach with hands and arms; stoop, kneel, crouch or crawl