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

Pro QC International North America • Twingsburg, OH

3d • Onsite

About The Position

Pro QC International is seeking a Quality Auditor for ISO 13485 compliance. This role involves performing audits at client manufacturing sites, identifying risks, and assessing findings against ISO 13485 requirements. The auditor will communicate findings and issue reports within deadlines. This is a 1099 contract position with project durations that may vary.

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 manufacturing sites per Pro QC checklists.
• Using process audits to identify relevant risks and potential issues.
• Classifying audit findings against ISO 13485 requirements.
• Communicating findings with the audit team.
• Issuing audit reports within the due date.

What This Job Offers

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