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Quality Auditor
MXN 13,000-15,000/year
Indeed
Full-time
Onsite
No experience limit
No degree limit
5 de Febrero de 1917 2, Zona Industrial, 56600 Chalco de Díaz Covarrubias, Méx., Mexico
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Description

**Position Objective** Ensure compliance with quality standards and applicable national and international regulations (ISO 13485, among others) by conducting internal, process, and supplier audits, guaranteeing the conformity of the quality management system and continuous improvement. **Main Responsibilities** * Plan, conduct, and document internal audits of the Quality Management System. * Participate in external audits (certification bodies, customers, and health authorities). * Verify compliance with procedures, records, and controls in production, laboratory, maintenance, validations, and warehouse. * Evaluate and audit suppliers of raw materials, services, and finished products. * Follow up on corrective and preventive actions (CAPA). * Prepare and maintain updated audit reports and compliance matrices. * Support technical documentation reviews and change control processes. * Collaborate with production, engineering, and regulatory departments in implementing improvements. * Monitor quality system performance indicators. **Requirements** * **Education:** Bachelor's or engineering degree in Chemistry, Biomedical, Industrial, Biochemistry, or related field. * **Experience:** Minimum 2 to 3 years in auditing or quality control within the **medical devices**, pharmaceutical, or related industry. **Knowledge in:** * ISO 13485, ISO 9001, NOM 241 * Good Manufacturing Practices (GMP) * FDA 21 CFR Part 820 regulation * Document management and internal auditing * Growth opportunities * Statutory benefits We are looking for a **Quality Auditor** to join our team. If you have experience in quality assurance, internal audits, and procedure compliance, this opportunity is for you. **We Offer** Punctuality bonus Subsidized cafeteria Statutory benefits Free transportation in the area Work schedule: Monday to Friday from 8:00 a.m. to 5:00 p.m., Saturday from 8:00 a.m. to 12:00 p.m. Employment type: Full-time Salary: $13,000.00 - $15,000.00 per month Work location: On-site

Source:  indeed View original post
Juan García
Indeed · HR

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