SMC Ltd is hiring : Technical Writer in Town of Somerset

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About us : SMC Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. We value speed, technology, and exceptional performance, with decades of manufacturing experience and strong growth. We offer outstanding career opportunities for dedicated people.

Job Summary

Responsible for creating, editing, and maintaining comprehensive technical documentation for automated assembly systems used in medical and pharmaceutical devices. Translate complex engineering, software, and regulatory concepts into clear, user-friendly materials that comply with industry standards such as GAMP5, ISO 13485, FDA 21 CFR Part 820, and EU MDR. Collaborate with cross-functional teams—including engineers, quality, manufacturing, automation, and regulatory experts—to ensure accurate communication of automation processes from design specifications through user requirements to factory acceptance testing that will be translated into operational instructions.

Essential Job Duties and Responsibilities

• Author technical reports, validation protocols, and automation design and development documentation per GAMP 5 requirements for automated manufacturing equipment, ensuring compliance with AAMI / ISO standards and FDA guidelines; include SOPs, work instructions, equipment manuals, and process flow diagrams for manufacturing and automation systems.
• Collaborate with subject matter experts (SMEs) in automation engineering, manufacturing, and quality to gather and synthesize technical information to develop training materials and quick-reference guides for production technicians and operations, ensuring clarity for diverse audiences, including non-technical operators.
• Review and edit content for technical accuracy, consistency, and adherence to style guides, incorporating visuals like schematics and CAD drawings.
• Perform gap analyses on existing documentation and update legacy materials for new or updated automation features and processes.
• Conduct research on industry trends in medical device automation to support marketing collateral and white papers.
• Support quality audits by preparing documentation for internal reviews and external inspections, ensuring materials are audit-ready and traceable.
• Solicits feedback from internal and external customers; develops and implements improvements.
• Performs other duties as assigned.

Essential Qualifications

Desirable Qualifications

ADA Requirements

What SMC has to offer

SMC Ltd. is an equal opportunity employer. M / F / D / V; this organization uses E-Verify. Applicants may be subject to pre-employment screening including drug screening, reference checks, employment verifications, background screening, and / or skills assessments.

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