Quality Assistant

Description

Develop documentation for the Quality Management System; Analyze customer complaints and nonconformities; Schedule, plan, and convene critical review meetings and change control meetings; Prepare critical reviews to support corrective action decisions; Monitor new product registrations and maintenance with ANVISA, which may be handled by a third-party company; Develop and review instructions related to departments; Perform product registration/data entry in SAP according to ANVISA approval; Conduct training relevant to the quality area; Assist with technical documentation clearance for export products; Monitor external audits and inspections; Monitor label approval for packaging in accordance with current regulations; Maintain departmental organization; Comply with company policies and standards; Other duties inherent to the position. Qualifications and Specific Knowledge: Education in Quality Management, Pharmacy, Engineering, or related fields. Mandatory: Quality tools, nonconforming products, document and record control, internal audits, RDC 665:2022, ISO 13485:2016; ISO 9001, knowledge of quality management routines and risk management, fluent English. Employment Type: CLT Working Hours: Monday to Friday, from 7:00 AM to 4:48 PM Location: Cajuru neighborhood - Curitiba - PR Salary: To be negotiated Position Type: Full-time, permanent CLT Compensation: R$2.500,00 - R$2.600,00 per month Benefits: * Medical assistance * Dental assistance * Commercial agreements and discounts * Life insurance * Meal allowance * Transportation allowance Experience: * Quality Management Documentation (Mandatory) Workplace: On-site