QA Manager, LATAM

Convatec; São Paulo; Presencial; USD 80.000 - 100.000; Tempo integral

Resumo da oferta

A leading global medical products company is seeking a Quality Assurance professional to manage compliance activities and oversee quality management systems. The ideal candidate will have a strong background in the medical device industry and proficiency in English. This role involves ensuring adherence to local regulations and managing post-market surveillance activities.

Qualificações

• Experience in post-market quality assurance in the medical device industry.
• Proficiency in English is mandatory.
• Knowledge of ISO-13485:2016 and applicable regulations.

Responsabilidades

• Manage and execute quality compliance activities according to local regulations.
• Oversee distribution center quality activities, including audits.
• Implement and track CAPA processes.

Conhecimentos

English

Quality Assurance

Stakeholder Management

ISO-13485:2016

Formação académica

Bachelor’s degree in science

Bachelor’s degree in Engineering

Bachelor’s degree in Medical Technology

Descrição da oferta de emprego

Direct message the job poster from Convatec

Company Overview: Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we operate in almost 100 countries, committed to being forever caring. Our solutions offer benefits such as infection prevention, skin protection, improved patient outcomes, and reduced care costs. In 2023, Convatec's revenues exceeded $2 billion. The company is part of the FTSE 100 Index (LSE:CTEC). More information at Convatec.

Key Responsibilities:

Manage and execute quality compliance activities according to local regulations. Ensure renewal and maintenance of licenses and authorizations for medical devices and cosmetics in LATAM. Participate in audits, ensuring compliance with standards. Develop and maintain Quality Management System processes and SOPs. Coach and manage non-conformance and complaint processes, including complaint handling and trend monitoring. Oversee distribution center quality activities, including qualification, audits, and quality agreements. Manage post-market surveillance activities like recalls. Develop procedures for local labeling, coordinate with regulatory and supply chain teams. Implement and track CAPA processes. Organize internal training sessions on quality standards and procedures.

Skills & Experience:

• Bachelor’s degree in science, Engineering, or Medical Technology.
• Experience in post-market quality assurance in the medical device industry, with regional stakeholder management preferred.
• Proficiency in English is mandatory.
• Knowledge of ISO-13485:2016 and applicable regulations (ANVISA, RDCs, etc.).
• Experience with field safety actions is desirable.

Additional Details:

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job functions: Supply Chain, Management, Quality Assurance
• Industries: Medical Practices, Medical Equipment Manufacturing, Pharmaceutical Manufacturing