Remote Medical Device Auditor - Lead ISO 13485 & MDSAP

Intertek CEA; Boxborough, Northern (MA, KY); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical benefits

401(k) with company match

Generous vacation time

Job summary

Intertek is seeking an experienced Medical Device Auditor to lead and participate in 3rd party audits across multiple sites. The role requires extensive travel (3–5 nights per week) and living in the United States.

You will assess management systems for ISO 13485 compliance, train junior auditors, and interface with clients throughout the certification process. Applicants should have a biology/technical degree, 4+ years in medical device auditing, and strong communication, documentation, and

Qualifications

• 4 year college/university degree in a science or technical field or equivalent combination
• Minimum 4+ years of full-time work experience in a 3rd Party Auditing with Lead Auditor qualification in MDSAP and ISO 13485:2016
• Minimum 4+ years in medical device industry
• Minimum 2+ years in a quality management systems environment
• Willingness to travel extensively (domestic + some international)
• Valid unrestricted driver's license

Responsibilities

• Audit client management systems for compliance with ISO 13485 and regulatory requirements
• Assist clients with questions relevant to the audit and certification process
• Act as Lead Auditor or team member
• Coordinate audit activity with team members
• Review client's quality management system documentation
• Verify and document evidence of compliance and non-compliance
• Prepare audit report
• Review audit results with coordinators and team members
• Provide technical assistance to the medical team
• Support management in continuous improvement

Skills

Communication skills

Writing skills

Time management

Travel readiness

Education

Science/technical degree

Tools

Lead Auditor training

Job description

Intertek is seeking an experienced Medical Device Auditor to lead and participate in 3rd party audits across multiple sites. The role requires extensive travel (3–5 nights per week) and living in the United States.

You will assess management systems for ISO 13485 compliance, train junior auditors, and interface with clients throughout the certification process. Applicants should have a biology/technical degree, 4+ years in medical device auditing, and strong communication, documentation, and