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Technical Writer - Medical
Vimerse Infotech, Inc.Irvine, CA, United Statesjob_description.job_card.variable_days_ago
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job_description.job_card.job_descriptionExperience in working in Medical device development and design. Good understanding on product sterility, biocompatibility, labeling & packaging standards. Good understanding on Medical Quality Process and QA function. Good understanding on IFU, packaging, sterilization Validation / Verification protocols and Versioning activity, TMV, Process Validation, EU MDR remediation, IQ / OQ / PQ, packaging, Risk Management. Experience in Change Management Process / Tracking and compliance with QMS requirements. Assist project team to develop and maintain periodic status reports to keep management informed on project progress. Excellent verbal and written skills necessary in order to effectively communicate complex issues. Ability to maintain composure and adapt in a dynamic, fast-paced, customer-focused work environment characterized by rapid change, minimal lead times, and multiple competing priorities. Ability to effectively manage and execute multiple tasks and projects. Be a self-driven individual.
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Technical Writer • Irvine, CA, United States
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