Overview
QA Technician who provides day-to-day Quality support for the manufacturing lines to ensure continued effective and compliant processes. Key responsibilities include production audits,control of non-conforming product, quality metrics reporting, practice versus, procedure reviews, compliance to GMP and GDP, and supporting process improvements.
Responsibilities
* Provide quality assurance support for daily operational activities, with a focus on production auditing, non-conforming material management, incoming and in-process inspections, quality metrics reporting, procedure compliance, problem-solving, rework coordination, and process improvement initiatives.
* Prepare and maintain documentation to support operational effectiveness, product realization, and the Quality Management System (QMS).
* Deliver day-to-day quality support for manufacturing operations to ensure processes remain effective and compliant.
* Participate in regular production and planning meetings to provide quality input and oversight.
Key Skills
* Minimum 2-5 years’ experience in an operations role within the
* Medical Device or Pharmaceutical Industry
* Experience and understanding of regulations related to medical devices e.g. ISO 13485, MDR and applicable FDA Requirements.
* Experience in writing documentation in a regulated environment.
* Experience in conducting audits in a regulated environment
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