Chemical Auditor

Description

Job Summary: Ensure compliance of processes, products, and Quality Management Systems through internal audits and corrective action follow-up. Key Responsibilities: 1. Ensure regulatory compliance of the organization 2. Plan and conduct internal QMS audits 3. Collaborate with external audits and regulatory bodies **Job Description:** A leading manufacturer of medical devices is seeking: ***Quality Auditor – Chalco Zone*** Objective: Ensure compliance of processes, products, and Quality Management Systems (QMS) with applicable regulations through internal audits and corrective action follow-up, to maintain QMS effectiveness and ensure organizational regulatory compliance. **Job Responsibilities:** * Plan and conduct internal QMS audits in accordance with ISO 13485 guidelines and applicable regulations, ensuring objectivity and independence. * Prepare clear, detailed, and timely audit reports including findings, nonconformities, and areas for improvement. * Follow up on Corrective and Preventive Actions (CAPA) arising from internal and external audits. * Collaborate with external audits, including regulatory body and customer audits, providing documented evidence and technical support. * Train operational and administrative personnel on quality-related and regulatory compliance topics, as required. * Maintain updated records and documentation related to internal and external audits per regulatory requirements. **Requirements:** * Education: Chemical Engineer, Pharmacist-chemist, Industrial Chemist, or related field, with degree and professional license, or candidates nearing graduation. * Minimum 2 years of work experience in the field. * Knowledge of ISO 9001:2015, ISO 13485, NOM 241, NOM 059, FEUM. * Experience in internal and external audits. **Competencies and Skills:** * Ability to work under pressure * Teamwork * Sense of urgency * Punctuality * Organization * Proactivity * Problem-solving **We Offer:** * Base salary * 10% punctuality bonus * Statutory benefits * Subsidized cafeteria * Free transportation service within the zone * Additional benefits Work schedule: Monday to Friday, 8:00 AM to 5:00 PM; Saturdays, 8:00 AM to 12:00 PM Work location: Chalco, State of Mexico. Salary: $15,000\.00 \- $17,000\.00 per month Benefits: * Free parking * Grocery vouchers Workplace: On-site employment