Medical Device Lead Auditor

• Permanent
• $120k - 140k per year

Job Title: Medical Device Lead Auditor

Location:

Americas and the Caribbean, North America, United States (REMOTE)

Salary:

£120,000.00 – £140,000.00 Per annum

Job Duties:

• Lead and conduct audits of medical device manufacturing facilities
• Ensure compliance with regulatory requirements and industry standards
• Develop audit plans and schedules
• Review and evaluate audit findings
• Provide recommendations for corrective actions
• Prepare audit reports
• Communicate audit results to stakeholders

Required Qualifications:

• Bachelor’s degree in a related field
• Certification as a Lead Auditor – ISO 13485, MDSAP, MDD, MDR
• Understanding of medical device regulations
• Experience in auditing medical device manufacturing facilities

Education:

Bachelor’s degree in a related field

Experience:

Minimum of 5 years of experience in auditing medical device manufacturing facilities

Knowledge and Skills:

• Strong knowledge of medical device regulations
• Excellent auditing skills
• Attention to detail
• Effective communication skills
• Ability to work independently and as part of a team

Preferred Qualifications:

• Master’s degree in a related field
• Additional certifications in auditing or quality management

Working Conditions:

The role involves frequent travel to medical device manufacturing facilities in the Americas and the Caribbean region. Work hours are typically full-time, with occasional overtime required.