ISO 9001 & 13485 Lead Auditor (Freelance)
Pepat System Services
Management & Business Development
Job Summary
The Lead Auditor is responsible for assessing and evaluating the effectiveness, compliance, and efficiency of management systems within an organization. This includes performing audits in line with standards such as ISO 9001, ISO 13485 and relevant frameworks.
- Minimum Qualification : Degree
- Experience Level : Entry level
- Experience Length : 2 years
Job Description/Requirements
Responsibilities:
- Develop audit plans, schedules, and checklists tailored to the organization's management systems.
- Review policies, procedures, and previous audit reports to understand the scope and objectives.
- Communicate audit objectives and requirements to stakeholders.
- Perform internal and external audits to assess compliance with standards, regulations, and company policies.
- Interview personnel, observe operations, and review documentation to gather evidence.
- Evaluate the effectiveness of processes and identify areas for improvement.
- Document audit findings in detailed and structured reports.
- Present results to management, highlighting non-conformities and opportunities for improvement.
- Recommend corrective and preventive actions to address identified issues.
Requirements:
- Bachelor’s degree in Quality Management, Engineering, Environmental Science, or a related field.
- Certification as a Lead Auditor for standards such as ISO 9001, and ISO 13485.
- 2+ years of experience in auditing or implementing management systems.
- Familiarity with multiple management system frameworks is a plus.
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