Please let us know where you are, or where you would like to be in the world so we can point you in the right direction.
-
Medical Device Lead Auditor
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.