Document Specialist
hace 16 horas
This role is responsible for creating and maintaining accurate, clear, and concise documentation of manufacturing processes, equipment, and related systems within a regulated medical device environment.
Key Responsibilities:- Collaborate closely with Engineers (PD, PE, SE, and ME), SMEs and other stakeholders to gather information, clarify requirements, and ensure accuracy of documentation.
- Develop, write, and edit clear, concise, and accurate technical documentation, including Standard Operating Procedures (SOPs), Quality Management System documents, Equipment Specifications, Process Safety Information, Technical/Engineering Testing Plans and Reports, Product specifications, Training Manuals, and other engineering documents.
- Prepare, manage, and submit Engineering Change Orders through implementation.
- Follow up on the status of documentation release on the QMS system.
- Conduct thorough research and analysis to gather and synthesize technical information from various sources.
- Maintain and update existing documentation to reflect changes in processes, equipment, and industry standards.
- Ensure that all documentation adheres to established company standards, regulatory requirements (e.g., ISO 13485:2016 and 21 CFR 820), and industry best practices.
- Utilize technical writing tools and software (e.g., MS Word, MS Excel, MS PowerPoint, MS Visio, PDF Editor) to create and maintain high-quality documentation.
- A minimum of an Associate's degree or a related field (Technical Writing, Journalism, English, Writing, Communications).
- Proficiency in technical writing tools and software (e.g., MS Word, MS Excel, MS PowerPoint, MS Visio, PDF Editor).
- Excellent English skills (B2 level or higher).
- A minimum of 3 years of experience as a Technical Writer in a Regulated Manufacturing Industry.
- Strong understanding of Regulated Manufacturing Processes and Change Management.
- Experience and knowledge in a medical regulated organization utilizing ISO 13485 & 21 CFR 820 is preferred.
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