Qa Specialist
CurrentDesign, implement, and maintain a robust ISO 13485-compliant QMS to ensure quality and regulatory compliance.Manage the training program, deliver classroom instruction, and onboarding new hires to ensure they possess the necessary skills and knowledge.Facilitate and support NCRs, CAPAs and CCRs.Lead internal audits of the QMS and support external certification body, customer, and supplier audits to ensure continual improvement.Compile weekly quality reports and maintain key performance indicators (KPIs) to track progress and identify areas for improvement.Chair monthly quality board meetings, fostering communication and collaboration across departments on quality initiatives. Conduct thorough batch reviews and approve product releases, ensuring product quality and regulatory adherence. Generate and review CoAs and SDSs.