- Develop, review, and maintain technical documentation related to products and engineering processes;
- Ensure all documentation complies with regulatory standards and quality requirements;
- Collaborate closely with engineering and production teams to collect and document accurate technical information;
- Participate in the development of new products, ensuring proper documentation from conception to production;
- Manage and update quality control records and related documentation;
- Conduct documentation audits to ensure continuous compliance;
- Assist in preparing technical reports, user manuals, and other support materials;
- Implement and maintain an efficient document management system.
- Bachelor's degree in Engineering, Health Sciences, or a related field;
- Minimum of 3 years of experience in technical documentation in the medical device industry or related sectors;
- Knowledge of ISO 13485 standards and ANVISA regulations for medical devices;
- Ability to write clear and precise technical documents;
- Excellent communication skills and attention to detail;
- Proactive and able to work independently.
- Certified Professional in Healthcare Quality (CPHQ);
- Certified Quality Auditor (CQA);
- Certified Quality Engineer (CQE);
- 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;
- Knowledge in project methodologies: Scrum, Kanban, Lean, PMI/PMBOK, Six Sigma.
- Fluent in English.
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Technical Documentation Analyst for Engineering - São José dos Campos, SP, Brasil - IONIC Health
Descrição
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:
Requirements:
Preferred Qualifications:
Language:
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