Lead Auditor

Job Summary

MUST HAVES

• Verify and document evidence of compliance / non-compliance
• Prepare audit report
• Establish map of DHF document trace
• Help populate Design Trace Matrix
• Review audit results with key stakeholders
• Absorb corrective actions

Duties

Act as lead auditor in assessing our medical device DHF for compliance with respect to internal Quality Systems and other relevant standards, specifically ISO 13485, ISO 14971 and/or GMP regulatory requirements related to the medical device.

• Assist associates with questions relevant to the audit
• Act as Lead Auditor
• Cook up audit activity with team members
• Review quality management system documentation
• Verify and document evidence of compliance and non-compliance
• Prepare audit report
• Review audit results with key stakeholders and assessment team members. Generate presentations concerning audit results, when required
• Absorb corrective action requirements resulting from assessments
• Participate in audit meetings
• Review audit reports and provide technical assistance to the project team

Requirements

• In-depth knowledge of auditing Design History Files in the medical device industry
• A minimum of 5+ years of full-time work experience in a medical device or related industry
• Certified in Lead Auditor training for ISO 13485
• Training in quality management systems and/or relevant regulatory requirements
• Strong communication and interpersonal skills
• Sound judgment, organizational, and analytical skills
• Excellent computer and writing skills
• Ability to define problems, collect data, establish facts, and draw valid conclusions
• Ability to exercise effective time management skills in completion of assignments