Role Summary: 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.
The ideal candidate possesses strong technical writing, communication, and organizational skills, with a deep understanding of process engineering principles.
The candidate will collaborate closely with Engineers (PD, PE, SE, and ME), Manufacturing Production Leads, Manufacturing Operators, Technicians, and other Subject Matter Experts (SMEs) to ensure the quality and compliance of all documentation.
Essential Duties and Responsibilities: Collaborate closely with engineers (PD, PE, SE, and ME), SMEs and other stakeholders gather information, clarify requirements, and ensure accuracy of documentation.
Develop, write, and edit clear concise and accurate technical documentation, including but not limited to: 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 Order through its implementation.
Follow up 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 Power Point, MS Visio, PDF Editor) to create and maintain high-quality documentation.
Participate in meetings to provide inputs on documentation requirements and ensure effective communication.
Train and mentor junior technical writers as needed.
Works under general direction.
Performs other duties and responsibilities as assigned.
Education & Experience Requirements: Associates/Technical degree or "In-process" of getting Engineering Degree (e.g., Manufacturing, Chemical, Mechanical, Electrical) or a related field (Technical Writing, Journalism, English, Writing, Communications) Proficiency in technical writing tools and software (e.g., MS Word, MS Excel, MS Power Point, MS Visio, PDF Editor).
Excellent English skills B2 level (C1 preferred).
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.
Strong attention to detail and accuracy.
Ability to work independently and as part of a team.
Job Posted by ApplicantPro