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Medical Device Auditor Jobs (NOW HIRING)

Stryker

Senior Medical Device Driver

New Orleans, LA · On-site

$23.90/hr

The Senior Medical Device Driver oversees daily warehouse and logistics operations, including the ... In this role, you will ensure accurate inventory control through auditing, reporting, and adherence ...

SQA Services

Quality Auditor - Pharmaceutical

Chicago, IL · Remote

$1.3K/day

Assure quality in the supply chains of various clients within the pharmaceutical, medical device ... Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211 ...

SQA Services

Quality Auditor - Pharmaceutical

Warren, IN · Remote

$1.3K/day

Assure quality in the supply chains of various clients within the pharmaceutical, medical device ... Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211 ...

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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.

More about Medical Device Auditor jobs
What cities are hiring for Medical Device Auditor jobs? Cities with the most Medical Device Auditor job openings:
What are the most commonly searched types of Medical Device Auditor jobs? The most popular types of Medical Device Auditor jobs are:
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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.
Supplier Quality Auditor

Supplier Quality Auditor

Lynkx Staffing LLC

Saddle Brook, NJ

Full-time

Posted 5 days ago

Job description

Supplier Quality AuditorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Supplier Quality Auditor ensures and promotes compliance through external auditing of company's suppliers; vendors/ laboratory services/service providers/manufacturers for the Allendale, NJ and Mountain View, CA sites based on company's procedures and external regulatory requirements, including but not limited to current FDA Quality System Regulations; 21 CFR Parts 210/211 (cGMP), 21 CFR Part 1271 (GTP), 21 CFR Parts 50/54/56/312 (GCP), 21 CFR Pat 58 (GLP), ICH Q7, Q9, Q10, 21 CFR Part 11 and Data Integrity and Eudralex Volume 4 Guidelines.The Supplier Quality Auditor position will be responsible for the development of a risk-based auditing program for company and management of the Approved Supplier List. The Supplier Quality Auditor will conduct external supplier/vendor/manufacturer audits and harmonize the supplier qualification process across all sites. The Supplier Quality Auditor supports qualification initiatives, continuous improvement, and regulatory compliance across all sites.
  • Develop and maintain a risk-based external auditing program for company harmonized across all sites.
  • Perform GAP analyses of the Approved Supplier List (ASL) of suppliers used at all company facilities to ensure complete profile.
  • Management of ASL to add suppliers and maintain approval status of all suppliers as needed.
  • Based on ASL status, conduct reviews and perform audits to qualify each supplier used.
  • Prepare external audit schedule and conduct audits per the schedule.
  • Prepare and complete audit reports and communicate audit information to cross functional teams within company and supplier within a timely manner.
  • Ensure adequate CAPAs are developed by suppliers and monitor CAPA closures.
  • Track audit findings for suppliers to completion and ensure timely closure of audit reports.
  • Act as a quality lead and liaison between suppliers and internal teams to identify new suppliers and identify and communicate issues that may impact quality, system gaps or cause interruptions in business continuity.
  • Maintain metrics on supplier audit findings used for oversight, qualification status, continuous improvement, and/or opportunities for reduction/alternate suppliers.
  • Maintain audit files and ensure all files are properly archived.
  • Author and review External Auditing, Supplier Qualification and Supplier Management Program and/or Quality Systems SOPs, as needed.
  • Ensure that Quality Agreements are generated and enforced at each supplier.
  • Ensure and promote compliance with applicable regulations (e.g., cGMPs, GTPs, etc.) and company and client SOPs.
  • Assist in other Quality System related responsibilities and provide Quality related support to various departments, as needed.
REQUIREMENTS
  • Minimum 5-8 years quality systems auditing experience in pharmaceutical, biologics, or medical device industry.
  • Auditor qualifications and certifications such as Certified Quality Auditor (CQA)/ASQ Certification, ISO Certification, etc.
  • Experience with auditing raw materials/excipients, components, and analytical and micro laboratories.
  • Proven ability to identify, collaborate, and resolve supplier related compliance issues.
  • In-depth knowledge and understanding of current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), ICH Q10, 21 CFR Part 11, Good Tissue Practices (GTPs) and Data Integrity principles,
  • EU and PMDA regulations knowledge and associated guidelines are a plus.
  • Bachelor’s Degree in the chemistry or biological sciences, engineering, or life sciences.
  • Certified Auditor or Lead Auditor credentials required.
  • Understanding of the manufacture and testing of cellular and gene therapies is desirable.
  • Working knowledge of routine laboratory operations, equipment and systems, production processes, and validation.
  • Experience in Quality Assurance, including the ability to identify and resolve compliance issues.
  • Sound knowledge of aseptic processing and supporting technologies.
  • Must have exceptional written and oral communication skills.
  • Exhibit professional mannerisms when dealing with Clients/Suppliers and company personnel
  • Ability to multi-task is essential.
  • Proficiency with IT skills, such as MS Office (Word, Excel, Outlook, PowerPoint) and SharePoint.
  • Ability to think strategically and tactically (strong detail-oriented).
  • Strong collaborative and influencing skills and ability to work well in a cross-functional, team matrixed environment as well as independent contributor.
  • Strong analytical and problem-solving skills.
  • Flexible and able to adapt to company growth and evolving responsibilities.
  • Multi-disciplinary knowledge across GxP functional areas.
  • Excellent organizational skills including efficiency, punctuality and attention to detail and managing multiple priorities.
  • Good verbal, written communication, and presentation skills.
  • Demonstrable multitasking, project management, and execution skills.
  • Good business acumen and strong team-oriented interpersonal skills, including communication, presentation, negotiation, influence.
  • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors.
  • Must have the ability to work in a team-oriented environment and with clients
  • Must be able to handle the standard/moderate noise of the manufacturing facility
  • Travel required (approx. 50%)
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.