We are seeking a detail‑oriented Technical Writer & Document Control to support the creation, revision, and management of regulated documentation within a quality‑driven manufacturing environment.
Please note this is an initial 3 month contract role with the view for permanency. Our client is seeking someone is available to join immediately. This role will focus on technical writing, document accuracy and maintaining compliant documentation systems in accordance with FDA, ISO 13485, GMP, and internal quality standards.
Key Responsibilities
Technical Writing & Documentation
Create, revise, format, and maintain technical documentation, including:
Standard Operating Procedures (SOPs)
Work Instructions
Forms, templates, and quality records
Collaborate with manufacturing, engineering, and quality teams to gather technical information and translate it into clear, accurate, and user‑friendly documentation.
Ensure all documents follow company formatting, version control, and regulatory requirements.
Review documentation for consistency, clarity, grammar, and compliance.
Document Control & Change Management
Manage document revision activities through the change control system.
Route, track, approve, and release controlled documents in a timely manner.
Maintain document histories, revision logs, and archival records.
Support document lifecycle activities including issuance, retrieval, scanning, filing, and archiving.
Compliance & Quality Support
Ensure documentation complies with FDA regulations, ISO 13485, GMP, and internal quality standards.
Support internal and external audits by providing accurate and traceable documentation records.
Assist with continuous improvement of documentation processes and templates.
Systems & Administrative Support
Maintain and update records within the Electronic Document Management System (EDMS).
Utilize Microsoft Office tools to develop and manage controlled documentation.
Support standardization and organization of quality documentation systems.
Required Skills & Qualifications
Experience
2–4 years of experience in technical writing, document control, or quality documentation within a regulated industry.
Experience in medical device, pharmaceutical, or manufacturing environments preferred.
Technical Skills
Strong technical writing, editing, and document formatting skills.
Proficiency in Microsoft Office Suite, particularly Word and Excel.
Experience working with Electronic Document Management Systems (EDMS).
Knowledge
Understanding of document control processes and quality systems.
Familiarity with ISO 13485, FDA 21 CFR Part 820, GMP, and controlled documentation practices.
Education
Level 6 diploma/certificate or equivalent qualification in Quality, Technical Communication, Life Sciences, or related discipline.
For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose
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