Hi everybody

Integral Operations Excellence | Lean Transformation | Industry 5.0 | Supply Chain Management

We are seeking a Freelance Quality Auditor to join our team in Cali, Colombia.

If you are interested in this position, please send your resume in English to

Key responsibilities

- Conducting Audits: Performing internal and external audits to assess the quality management system against ISO 13485 requirements and other relevant standards like FDA regulations.
- Ensuring Compliance: Verifying that processes and documentation meet regulatory requirements and industry best practices for medical devices.
- Identifying Issues: Identifying non-conformities and areas for improvement in the quality management system.
- Providing Recommendations: Recommending and helping implement corrective and preventive actions.
- Reporting Findings: Documenting audit results and communicating them to management.

Required skills and qualifications

- ISO 13485 Certification: Often, a specific ISO 13485 auditor certification is required, as well as experience conducting audits.
- Medical Device Experience: Experience with medical device manufacturing, quality systems,



and regulatory requirements is essential.
- Knowledge of Regulations: Familiarity with other relevant regulations, such as the FDA's 21 CFR Part 820, is frequently a requirement.
- Auditing Skills: Strong auditing skills, including the ability to conduct interviews, analyze data, and document findings.
- Soft Skills: Excellent communication, problem-solving, and interpersonal skills are crucial for managing challenging audit situations.

Language Skills

- English (very good speaking level, reading, and writing)

Computer Skill

- Good command of Microsoft Office tools such as Excel, Word, email Outlook, and PowerPoint

Job Type: Freelance (availability per project)

Seniority level

- Entry level

Employment type

- Full-time

Job function

- Quality Assurance

Industries

- Transportation, Logistics, Supply Chain and Storage

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📌 Freelance Quality Auditor ISO 13485 (Cali)
🏢 Pro QC International
📍 Cali