Technical Documentation Analyst for Engineering

3 semanas atrás


São José dos Campos São Paulo, Estado de São Paulo, Brasil IONIC Health Tempo inteiro

About the Company:

We are a leading medical device manufacturer committed to innovation and excellence in delivering safe and effective products. We are seeking a dedicated and qualified professional to join our Engineering team, focusing on technical documentation.


About this position:

On-site position in São José dos Campos, São Paulo, Brazil. Full-time contract as a service provider (PJ). Collaborative and stimulating environment with many challenges.


Responsibilities:

  1. Develop, review, and maintain technical documentation related to products and engineering processes;
  2. Ensure all documentation complies with regulatory standards and quality requirements;
  3. Collaborate closely with engineering and production teams to collect and document accurate technical information;
  4. Participate in the development of new products, ensuring proper documentation from conception to production;
  5. Manage and update quality control records and related documentation;
  6. Conduct documentation audits to ensure continuous compliance;
  7. Assist in preparing technical reports, user manuals, and other support materials;
  8. Implement and maintain an efficient document management system.


Requirements:

  1. Bachelor's degree in Engineering, Health Sciences, or a related field;
  2. Minimum of 3 years of experience in technical documentation in the medical device industry or related sectors;
  3. Knowledge of ISO 13485 standards and ANVISA regulations for medical devices;
  4. Ability to write clear and precise technical documents;
  5. Excellent communication skills and attention to detail;
  6. Proactive and able to work independently.


Preferred Qualifications:

  1. Certified Professional in Healthcare Quality (CPHQ);
  2. Certified Quality Auditor (CQA);
  3. Certified Quality Engineer (CQE);
  4. Knowledge in methodologies for technical documentation management: Content Management Systems (CMS), Lean Documentation, Quality Management Systems (QMS), Version Control Systems (VCS), Compliance and Regulatory Documentation;
  5. Knowledge in project methodologies: Scrum, Kanban, Lean, PMI/PMBOK, Six Sigma.


Language:

  1. Fluent in English.


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