Quality Auditor ISO 13485- Twinsburg, OH (1099 Contractor)

Pro QC International North America • Twinsburg, OH

4d • Onsite

About The Position

This role involves performing audits at client supplier manufacturing sites using Pro QC checklists. The auditor will identify risks and potential issues through process audits, classify findings against ISO 13485 requirements, and communicate these findings to the audit team, issuing a report by the due date. This is a 1099 contractor position with a current project duration of 2-4 days, though project duration may vary based on client needs. The current project requires 8-hour days, but contractor schedules can vary based on site availability. Travel to Twinsburg, OH, and surrounding areas is required.

Requirements

• ISO 13485 certified or trained
• Manufacturing and operations background
• Medical device expertise
• 2–4+ years in quality management or medical device industry
• Experience with QMS processes (CAPA, validation, design controls, etc.)

Responsibilities

• Performing audits at client supplier manufacturing sites per Pro QC checklists.
• Using the process audit to identify relevant risks and point out potential issues.
• Classifying audit findings against ISO 13485 requirements.
• Communicating findings with the audit team and issuing an audit report within the due date.

What This Job Offers

• Career Level: Mid Level
• Education Level: No Education Listed