QA Manager, LATAM

ConvaTec Group; São Paulo; Presencial; BRL 80.000 - 100.000; Tempo integral

Resumo da oferta

A leading global medical products company is seeking a Quality Assurance Manager to oversee compliance activities and manage quality systems in LATAM. The ideal candidate will have a science or engineering background and experience in the medical device industry. Key responsibilities include managing licenses, conducting audits, and ensuring quality standards are met. This full-time position offers an opportunity to contribute to improving patient outcomes through effective quality management.

Qualificações

• Experience in post-market quality assurance in the medical device industry.
• Proficiency in English is mandatory.

Responsabilidades

• Manage and execute quality compliance activities as required by local regulations.
• Ensure renewal of company licenses for medical devices in LATAM countries.
• Participate in internal and external audits.

Conhecimentos

Quality Management Systems

Regulatory Compliance

Stakeholder Management

Coaching

Customer Communication

Formação académica

Bachelor’s degree in science

Bachelor’s degree in Engineering

Bachelor’s degree in Medical Technology

Descrição da oferta de emprego

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Direct message the job poster from Convatec

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 provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com

Key Responsibilities:

Specific responsibilities of the role include, but are not limited to:

• Manage and execute quality compliance activities as required by local regulations.
• Ensure renewal and maintenance of company licenses and authorizations for medical devices and cosmetics in LATAM countries.
• Participate in internal and external audits, ensuring compliance with standards and best practices.
• Establish and maintain management processes and SOPs according to local regulations. Collaborate with different functions to implement processes. Develop, write, implement, and maintain documented QA procedures. Monitor and support the management of the quality system, review procedures, and ensure quality records are up to date. Input and update data in global Convatec systems.
• Coach QA Analysts and manage non-conformities based on warehouse input. Handle customer complaints, ensure timely reporting, monitor defect trends, and escalate issues as needed. Manage customer communication and follow up on overdue complaints.
• Manage distribution center quality activities, including qualification, documentation, audits, complaint investigations, and supplier quality management.
• Execute post-market surveillance activities such as recalls and corrections, consolidating responses and reporting to Global Quality.
• Develop and maintain procedures for local labeling activities, working with Regulatory and Sales teams on artwork and implementation.
• Implement and track CAPA activities across LATAM, ensuring timely closure.
• Organize and conduct internal training sessions on regulatory standards and quality procedures. Maintain training matrices and curricular.

Skills & Experience:

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

Additional Details:

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