ISO Lead Auditor
Job in
Minneapolis, Hennepin County, Minnesota, 55400, USA
Listed on 2026-02-16
Listing for:
Klaston Management
Full Time
position Listed on 2026-02-16
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Klaston Management is seeking a highly qualified professional to perform internal audits in accordance with ISO 13485 (Quality Management Systems for Medical Devices).
Main Responsibilities:
- Plan, conduct, and document internal audits in compliance with ISO 13485 requirements;
- Assess the effectiveness and conformity of Quality Management Systems;
- Identify nonconformities, risks, and opportunities for improvement;
- Prepare clear, accurate, and complete audit reports;
- Monitor and support corrective and preventive action processes;
- Maintain professional and ethical communication with clients and internal stakeholders.
Knowledge, Skills, and Abilities:
- Highly organized professional with strong attention to detail;
- Ability to work independently and manage multiple priorities;
- Availability for domestic and international travel;
- Valid passport and driver’s license;
- Minimum of three (3) years of proven experience conducting ISO 13485 audits;
If you're interested please send your CV to
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