ISO 13485 and FDA QMSR Internal Auditor - Medical Devices

Novo Surgical Inc. is seeking an experienced, independent auditor to conduct an internal audit of our medical-device Quality Management System. We are an FDA-registered and ISO 13485-certified company specializing in surgical instruments. Audit Framework 1. ISO 13485:2016 2. FDA 21 CFR Part 820 QMSR 3. Applicable FDA requirements, including 21 CFR Parts 4. ISO 14971, where applicable 5. Company procedures and records Scope of Work Conduct an independent, risk-based internal audit of our QMS against the applicable regulatory and company requirements. Required Deliverables 1. Audit plan and checklist using the template provided by Novo Surgical 2. Completed internal audit report 3. Findings supported by objective evidence and applicable requirements 4. Classification of nonconformities, if any 5. Recommendations and priority actions, if any Preferred Qualifications 1. Must have ISO 13485 Lead Auditor certification or equivalent 2. At least two years of medical-device auditing experience is preferred 3. Strong knowledge of FDA QMSR requirements 4. Experience with FDA inspection readiness 5. Experience auditing medical-device manufacturers Please include your certifications and relevant experience. Also confirm whether you are available remotely, onsite in Illinois, USA, or both.