Travel-Based Medical Device Auditor

Intertek CEA; Arlington Heights, Northern (IL, KY); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k) with company match

Generous vacation / PTO

Tuition reimbursement

Job summary

Intertek is seeking a Medical Device Auditor to lead or participate in audits of client management systems worldwide. This remote role requires frequent travel and a strong background in ISO 13485 and GMP regulatory requirements for medical devices.

The ideal candidate holds a science/engineering degree, 4+ years in the medical device sector, and 2+ years in a quality management environment with auditing experience. Willingness to travel domestically and internationally is essential.

Qualifications

• 4-year college/ university degree in a science or technical field or equivalent experience.
• 4+ years of full-time work in medical device or related industry.
• 2+ years in a quality management systems environment (auditing, CAPA, complaints).
• Lead Auditor training completed or willing to train.
• Willingness to travel extensively domestically; some international travel may be needed.

Responsibilities

• Audit client management systems for ISO 13485 and regulatory compliance.
• Lead Auditor or team member on audits; coordinate with clients and team.
• Travel 3–5 nights per week to client sites; liaise with clients during audits.
• Prepare audit reports and support corrective actions; present results when required.
• Assist with continuous improvement initiatives within the client’s quality system.

Skills

Strong communication

Excellent writing

Travel willingness

Time management

Education

Bachelor's in science/engineering

Tools

ISO 13485 knowledge

GMP knowledge

Job description

Intertek is seeking a Medical Device Auditor to lead or participate in audits of client management systems worldwide. This remote role requires frequent travel and a strong background in ISO 13485 and GMP regulatory requirements for medical devices.

The ideal candidate holds a science/engineering degree, 4+ years in the medical device sector, and 2+ years in a quality management environment with auditing experience. Willingness to travel domestically and internationally is essential.