Freelance Quality Auditor ISO 13485

Pro QC International; Cali; On-site; COP 4,000,000 - 10,000,000; Full time

Job summary

A global quality assurance company is seeking a Freelance Quality Auditor in Cali, Colombia. The role involves conducting audits, ensuring compliance with ISO 13485 and FDA regulations, and identifying areas for improvement. The ideal candidate has strong auditing skills, experience in medical device quality systems, and proficient English communication. This is a full-time freelance position, availability per project.

Qualifications

• ISO 13485 auditor certification and experience conducting audits.
• Experience with medical device manufacturing and regulatory requirements.
• Familiarity with the FDA's 21 CFR Part 820.
• Strong auditing skills to analyze data and document findings.
• Excellent communication and problem-solving skills.

Responsibilities

• Conduct internal and external audits to assess quality management systems.
• Ensure compliance with regulatory requirements and industry best practices.
• Identify non-conformities and recommend improvements.
• Document audit results and communicate them effectively.
• Document audit findings and communicate them to management.

Skills

ISO 13485 Certification

Medical Device Experience

Knowledge of Regulations

Auditing Skills

Soft Skills

English proficiency

Microsoft Office proficiency

Tools

Microsoft Office

Job description

Hi everybody!

Global 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 [e-mail].

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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