Klaston Management · 14 hours ago
ISO 13485 Lead Auditor
Minneapolis, MN
Contract
Onsite
Mid Level
3+ years expKlaston Management is seeking a highly qualified professional to perform internal audits in accordance with ISO 13485. The role involves planning, conducting, and documenting internal audits while assessing the effectiveness of Quality Management Systems in the medical devices sector.
ConsultingOutsourcingTraining
Hiring Manager
Gabrielle Rosa
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
Qualification
Required
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
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
ISO 13485 Lead Auditor Training Course (mandatory)
Company
Klaston Management
Klaston Management offers consulting, auditing, and training for ISO management systems and compliance.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase