3M Quality Assurance Specialist - Medical Devices 

Brazil, São Paulo 

981418607

Quality Assurance Specialist - Medical Devices, Sumaré/SP

AsQuality Assurance Specialistyou will play a key role for lead the Quality Management System (QMS) for 3M Medical Devices in accordance with ANVISA Good Manufacturing Practices – RDC 665/2022 (Brazilian Health Regulatory Agency) requirements in Sumaré/SP. In this role you will be ableleverage your broad knowledge and extensive experience to address complex situations and identify opportunities for process improvements. Your expertise will be crucial in maintaining high standards of quality and compliance, driving continuous improvement, and ensuring the successful commercialization of our medical devices in the Brazilian market.

The impact you will make in this role

• Ensure compliance with GoodManufacturing/StoragePractices and standard operating procedures.
• Maintain a robust Quality Management System (QMS) for 3M medical devices, aligned with local regulatory requirements and corporate guidelines. Ensure proper updates are made in alignment with area focal points and process releases.
• Ensure that global 3M Medical Devices policies impacting the Quality System are appropriately addressed by relevant QMS procedures.
• Oversee Corrective and Preventive Actions (CAPA).
• Lead internal and external audits.
• Ensure the correct application of the Change Management Process.
• Implement new standards, laws, requirements for the QMS (or customer)
• Ensure the training of new employees.
• Manage risk effectively.
• Provide technical advice to the legal representative regarding the characteristics of medical devices and ensure compliance with current regulations.

Your Skills and Expertise

To set you up for success in this role from day one, 3M is looking for candidates who must have the following qualifications:

• Bachelor’s degree in Pharmacy, Biology, Engineering, or a related field.
• Experience in a similar position with medical devices
• Advanced knowledge of quality management systems and post-marketing product surveillance activities.
• Knowledge of ANVISA quality requirements for medical devices, including good distribution and storage practices within the country.
• Knowledge of ISO 13485 requirements. Lead Auditor Certification is a differentiator.
• Ability to work cross-functionally on multiple projects, solve problems, and communicate issues effectively.
• Ability to execute project/program tasks with general supervision and minimal guidance.
• Fluency in English.

Additional qualifications that could help you succeed even further in this role include:

• Proficiency in Spanish.

Supporting Your Well-being

Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.

Please access the linked document by clicking select the country where you are applying for employment, and review. Before submitting your application, you will be asked to confirm your agreement with the terms.