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

Pro QC International North America • Akron, OH

4d • Onsite

About The Position

Pro QC International is seeking a Quality Auditor with ISO 13485 certification or training to perform audits at client supplier manufacturing sites. The role involves using process audits to identify risks and potential issues, classifying audit findings against ISO 13485 requirements, communicating findings with the audit team, and issuing audit reports on time. This is a 1099 contract role with project durations that may vary based on client needs.

Requirements

• ISO 13485 certified or trained
• Require a manufacturing and operations background and 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 the manufacturing sites of our clients' suppliers per Pro QC checklists.
• Using the process audit to identify relevant risks and point out potential issues.
• Looking at audit findings and classifying them against the ISO 13485 requirements.
• Communicating findings with the audit team.
• Issuing audit report within due day.

What This Job Offers

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