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BSI Prof Serv EHS West

ISO 18081,000 1901ISO90 ISO 13485 QMS （MUST） （） ＊ （） ＊ （） （WANT） / ＊ＢＳＩ ：（） ＊ISO13485 ：9：00～17：30（60） ：14（） ： ：（1）（60） Medical ...

BSI Group

ISO 18081,000 1901ISO90 ISO 13485 QMS （MUST） （） ＊ （） ＊ （） （WANT） / ＊ＢＳＩ ：（） ＊ISO13485 ：9：00～17：30（60） ：14（） ： ：（1）（60） Medical ...

DivIHN Integration Inc

Quality Manager

Oneonta, NY · On-site

This facility is undergoing a Quality System Transformation from ISO 9001 to ISO 13485. Looking for minimum of 2 years Project Management experience with managing this type of transition. ETQ ...

LC Industries

Manager, Quality

Durham, NC · On-site

With integration of ISO 9001 (globally) recognized standard for Quality Management Systems and ISO 13485 (internationally recognized standard for Quality Management Systems designed for the medical ...

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How much do iso 13485 jobs pay per hour?

As of Aug 6, 2026, the average hourly pay for iso 13485 in the United States is $21.09, according to ZipRecruiter salary data. Most workers in this role earn between $18.27 and $21.63 per hour, depending on experience, location, and employer.

What are the typical day-to-day responsibilities of someone working in an ISO 13485 quality assurance role?

Professionals in an ISO 13485 quality assurance role are typically responsible for developing, implementing, and maintaining quality management systems specific to medical devices. Their daily tasks include preparing documentation, conducting internal audits, ensuring compliance with regulatory standards, managing nonconformances, and coordinating corrective actions. They often collaborate closely with engineering, manufacturing, and regulatory affairs teams to address quality issues and facilitate continuous improvement. This position involves significant attention to detail and communication to uphold the organization’s quality objectives and regulatory commitments.

What is an ISO 13485?

An ISO 13485 job typically involves roles in quality management, regulatory compliance, and manufacturing within the medical device industry. Professionals in these roles ensure that companies adhere to ISO 13485, the international standard for quality management systems in medical devices. Responsibilities may include managing audits, maintaining documentation, overseeing regulatory compliance, and improving quality processes. These jobs are crucial for ensuring product safety, consistency, and compliance with regulatory requirements.

What are the key skills and qualifications needed to thrive in the ISO 13485 position, and why are they important?

To thrive in an ISO 13485 role, you need a strong understanding of quality management systems for medical devices, regulatory requirements, and risk management principles, often supported by a background in engineering, life sciences, or quality assurance. Familiarity with audit processes, CAPA (Corrective and Preventive Action) systems, and certifications like Certified Quality Auditor (CQA) or ISO 13485 Lead Auditor are highly valued. Attention to detail, problem-solving abilities, and effective communication set outstanding candidates apart. These skills ensure compliance with stringent regulations and help maintain product quality and patient safety in the medical device industry.

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Iso 13485 jobs near you
Infographic showing various Iso 13485 job openings in the United States as of August 2026, with employment types broken down into 80% Full Time, and 20% Contract. Highlights an 80% In-person, and 20% Remote job distribution, with an average salary of $43,861 per year, or $21.1 per hour.

ISO 13485 Lead Auditor - Contractor and Full-time Opportunities

Smithers Group

Fairlawn, OH

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 2 days ago

New

Job description

The Quality Assessments Division of Smithers is seeking experienced ISO 13485 Third-Party Auditors to perform assessment and certification activities for medical device manufacturers and related organizations against ISO 13485 requirements and applicable regulatory standards. Your goal is to build positive relationships with our clients while providing quality auditing and exceptional client services while maintaining a high level of integrity and impartiality. We are hiring for both full-time and contract opportunities.

The Quality Assessments Division of Smithers (SQA) is a global, accredited third-party Certification Body. As a member of our audit team, you will play a critical role in helping clients demonstrate compliance while supporting Smithers' commitment to delivering accurate, timely, and high-touch certification services. If you are passionate about quality, regulatory excellence, and making a meaningful impact in the medical device industry, we encourage you to join our team.

Duties:

  • Conduct audits to evaluate medical device quality management systems for conformity with ISO 13485 and applicable regulatory requirements.
  • Prepare audit plans, review client documentation, and assess readiness for certification activities.
  • Perform assessments of client facilities, processes, and quality management systems to determine compliance with certification requirements.
  • Evaluate documented information, operational processes, and quality system implementation to verify the effectiveness of the management system.
  • Identify and document nonconformities, observations, and opportunities for improvement.
  • Maintain complete and accurate audit records in accordance with accreditation requirements and internal procedures.
  • Submit expense reports and other critical audit documentation within established timelines.
  • Maintain acquired auditor credentials.

Qualifications:

  • Experience in the entire process of auditing medical device quality management systems, including review of documentation and risk management of applicable medical devices, parts or services, implementation audit, and audit reporting.
  • Experience participating as a trainee in a minimum of four audits totaling at least 20 days in an accredited QMS program, 50% of which shall be against ISO 13485, preferably in an accredited program, and the rest in any other accredited QMS program.

In addition to the above criteria, audit team leaders shall fulfill the following:

  • Successfully completed the Audit Team Leader role, under the supervision of a qualified Lead Auditor, for at least three ISO 13485 third-party certification audits.

Why Join Smithers Full Time?

  • Variable salary commensurate with experience and work efficiency
  • Medical, dental, and vision benefit plan
  • 401(k) retirement savings plan
  • Life insurance and AD&D
  • Short-term and long-term disability coverage
  • Wellness Program
  • Employee Assistance Program (EAP)
  • Business Operation System (BOS) – SQA Audit Management Platform
  • Training and development support
  • Flexible work schedule
  • Assignment priority

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