Remote Travel Medical Device Auditor — ISO 13485 Expert

Intertek Global; United States; Remote; USD 90,000 - 140,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) with company match

Vacation / PTO

Tuition reimbursement

Job summary

Intertek is seeking an experienced Medical Device Auditor to join its Travel-based team as a 3rd Party Qualified Auditor. You will lead or participate in audits across client management systems, specializing in ISO 13485 and MDSAP, and you will train junior auditors as needed.

The role is remote and requires traveling 3–5 nights per week to client sites in the United States, Canada, and Mexico as applicable. A science/technical degree and 4+ years of audit experience are essential.

Qualifications

• 4 year college/university degree in a science or technical field or equivalent.
• 4+ years of full-time work experience in 3rd party auditing with Lead Auditor qualification in MDSAP and ISO 13485:2016.
• 4+ years in medical device industry and 2+ years in a quality management systems environment.
• Willingness and ability to travel extensively, primarily domestic with some international travel.

Responsibilities

• Audit client management systems for compliance with ISO 13485, regulatory requirements and GMP standards.
• Lead Auditor or team member in audits and coordinate audit activity with team members.
• Train lower-graded auditors through witness audits and education.
• Prepare audit reports and present results to clients and certification boards as required.
• Support management in continuous improvement and provide status updates on initiatives.

Skills

Lead Auditor

Auditing Experience

Regulatory Knowledge

Travel Flexibility

Education

Science/Technical Degree

Job description

Intertek is seeking an experienced Medical Device Auditor to join its Travel-based team as a 3rd Party Qualified Auditor. You will lead or participate in audits across client management systems, specializing in ISO 13485 and MDSAP, and you will train junior auditors as needed.

The role is remote and requires traveling 3–5 nights per week to client sites in the United States, Canada, and Mexico as applicable. A science/technical degree and 4+ years of audit experience are essential.