We are seeking a meticulous and proactive Technical Writer to join our team. In this role, you will be responsible for the preparation, updating, and completion of documentation related to Manufacturing, Engineering, Supply Chain, and Quality departments. This position requires collaboration with cross-functional teams to ensure all documents, including SOPs and Work Instructions, meet Quality Management System standards and business needs.

Key Responsibilities:

• Document Preparation: Prepare, update, and complete documents, ensuring compliance with quality standards and regulatory requirements.
• Cross-Functional Collaboration: Work closely with cross-functional teams to drive the accurate and timely completion of high-quality documents.
• Procedure Documentation: Lead the identification and documentation of procedures that accurately reflect current practices across departments.
• Data Analysis: Gather and analyze data to inform and complete document updates and preparation.
• Compliance Assurance: Ensure that all SOPs, Work Instructions, and other documents comply with the company’s Quality Management System and relevant regulations.
• Timely Updates: Manage the timely preparation and updating of SOPs and Work Instructions to meet business and compliance needs.
• Regulatory Support: Participate in regulatory inspections, providing information on SOPs and Work Instructions as required.
• Continuous Improvement: Drive improvements in documentation practices, ensuring they meet the needs of the business and customers while eliminating non-value-added activities.
• Coaching and Compliance: Promote a culture of compliance and continuous improvement, providing training and coaching to ensure document-related compliance across the organization.
• Adherence to Policies: Ensure compliance with site Environmental, Health and Safety regulations, corporate policies, and the company’s Code of Conduct.
• Additional Duties: Perform additional tasks as requested by the SAP Project Lead or Business Unit Manager.

Qualifications:

• Education: A third-level qualification in Engineering, Quality, Science, or a related discipline is required.
• Experience: At least 3+ years of experience in a regulated environment such as Medical, Pharmaceutical, or high-volume manufacturing.
• Quality Systems Knowledge: Working knowledge of quality systems such as ISO 13485, 21 CFR Part 820, and EU GMP is essential.
• Technical Expertise: Strong knowledge of Injection Moulding processes, ancillary equipment, automation systems, and technical writing.
• Statistical Knowledge: Proficiency in statistics, data analytics, and Statistical Process Control (SPC), with experience using statistical packages.
• Communication Skills: Excellent written and verbal communication skills are essential, with the ability to clearly document work and interact across various departments.
• Computer Proficiency: Strong knowledge of integrated manufacturing systems, word processing, and spreadsheet software.
• Organizational Skills: Ability to prioritize tasks, manage multiple projects, and work effectively in a fast-paced environment.
• Collaboration: Experience working in a matrixed team environment with the ability to collaborate across functional teams.
• Independent Working: Ability to work independently while managing concurrent projects and tasks.
• Lean Thinking: Knowledge of lean principles, VA/NVA analysis, and waste reduction (TIMWOOD) is an advantage.
• Judgment and Confidentiality: Ability to make independent and sound judgments, maintain confidentiality, and resolve conflicts effectively.