Quality Assurance Analyst

Description

Job Summary: Quality professional to oversee and maintain the Quality Management System, including document development and revision, nonconformance handling, and audit execution. Key Highlights: 1. Leader in the medical-hospital supplies segment 2. Focus on Quality Management System (QMS) 3. Experience with audits and CAPA We are the **Kolplast Group**, a leading company in the medical-hospital supplies segment, located in the city of **Itupeva**. **Responsibilities and Duties:** * Develop, review, and control **Quality Management System (QMS)** documents, such as procedures, work instructions, forms, and records. * Support maintenance of the **QMS**, ensuring compliance with applicable regulatory requirements and quality standards, including **ISO 13485 and RDC 665**. * Lead and follow up on **nonconformities, deviations, and corrective and preventive actions (CAPA)**. * Conduct **internal audits** of the Quality Management System. * Attend and support **external and regulatory audits**. * Perform **impact analyses** related to changes in QMS processes and documents. * Support **deviation investigations** and conduct **root cause analyses**. * Monitor **quality indicators**, proposing continuous improvements when necessary. * Ensure proper **traceability, control, and organization of quality documentation**. * Adhere to **Good Manufacturing Practices (GMP)** and applicable regulatory requirements for the medical device sector. * Perform other related tasks of equivalent complexity within the scope of responsibilities, as requested. **Requirements and Qualifications:** * Prior experience with **Quality Management Systems in regulated companies**. * Experience in **developing, reviewing, and controlling QMS documents**. * Practical experience handling **nonconformities, CAPA, and audits**. * Profile: **organized, analytical, detail-oriented**. * Strong **written communication and technical writing skills**. * Ability to manage **regulatory deadlines and demands**. **Desirable:** * Experience in the **medical device industry or other regulated sectors**. * Knowledge of **ANVISA regulatory requirements**. * Familiarity with **ISO 13485 and RDC 665 standards**. * Familiarity with **INMETRO certifications or requirements**. * Prior experience in **ISO 13485-certified companies**. * Participation in **regulatory or certification audits**. **Requirements:** * Completed or ongoing undergraduate degree in **Engineering, Pharmacy, Biomedicine, Chemistry, Quality, or related fields**. **Benefits** * Medical assistance * Christmas basket * Parking * Profit-sharing program (PLR) * Life insurance * Meal voucher * Transportation voucher * Food allowance Employment type: Permanent CLT Salary: R$2.000,00 \- R$3.000,00 per month Benefits: * Medical assistance * Basic food basket * Partnership agreements and commercial discounts * Free parking * Profit sharing * Life insurance * Food allowance * Meal voucher * Transportation voucher Selection question(s): * Do you have experience with Quality Management System (QMS)? * Do you have experience handling nonconformities, deviations, and CAPA? * What is your experience with quality audits? * Do you have easy access to Itupeva/SP for on-site work? Work location: On-site