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Job Description
Quality Assurance Specialist - Medical Devices, Sumaré/SP
Collaborate with innovative 3Mers around the world
As Quality Assurance Specialist you 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 able to leverage 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 Good Manufacturing/Storage Practices 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
Qualifications
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
3M offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, 3M regularly benchmarks with other companies that are comparable in size and scope.
Imagine your future in 3M
At 3M, inspiration happens daily. Here, science is how the magic happens. Except it is not magic, it is the right science, applied in the right way by the people of 3M. Here, your ideas help shape everyday lives around the globe. Here, you matter. You inspire. Challenge. Create. Thrive. Here, you go. Apply now and discover inspired opportunities!
Learn more about 3M’s creative solutions to the world’s problems at www.3M.com or on Instagram, Facebook, and LinkedIn @3M.
A 3M é um empregador que oferece oportunidades iguais à todos. A 3M não discriminará nenhum candidato baseado em sua raça, cor, idade, religião, gênero, orientação sexual, identidade ou expressão de gênero, nacionalidade ou deficiência.
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.
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