Documentation Specialist for Regulated Manufacturing
hace 4 días
Job Summary: We are seeking a highly skilled Documentation Specialist to join our team at Atl Technology Costa Rica. 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 will possess strong technical writing, communication, and organizational skills, with a deep understanding of process engineering principles. They will collaborate closely with Engineers, SMEs, and other stakeholders to ensure the quality and compliance of all documentation.
Main Responsibilities:
- Develop, write, and edit 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 their implementation.
- 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.
Requirements: To be successful in this role, you will need an Associate's/Technical degree or 'in-process' of getting an Engineering Degree (e.g., Manufacturing, Chemical, Mechanical, Electrical) or a related field (Technical Writing, Journalism, English, Writing, Communications). You should also have proficiency in technical writing tools and software (e.g., MS Word, MS Excel, MS Power Point, MS Visio, PDF Editor).
Preferred Qualifications: A strong understanding of regulated manufacturing processes and change management, as well as experience and knowledge in a medical regulated organization utilizing ISO 13485 & 21 CFR 820, is preferred. You will also need excellent English skills (B2 level, C1 preferred) and 3+ years of experience as a Technical Writer in a regulated manufacturing industry.
Compensation and Benefits: The estimated salary for this position is around $65,000 - $80,000 per year, depending on experience. Additional benefits may include health insurance, retirement plans, and opportunities for professional growth and development.
We are an equal opportunity employer and welcome applications from qualified candidates. Please note that we do not discriminate based on race, gender, age, or any other characteristic protected by law.
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