ISO 13485 Quality Auditor for Medical Devices

Pro QC International; Cali; Presencial; COP 4.000.000 - 10.000.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

ISO 13485 Certification

Medical Device Experience

Knowledge of Regulations

Auditing Skills

Soft Skills

English proficiency

Microsoft Office proficiency

Descripción del empleo

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.