Regulatory Technician

Description

Job Summary: Quality professional responsible for monitoring and maintaining the ISO 9001 Quality Management System, promoting continuous improvement, and coordinating audits. Key Highlights: 1. Manage the ISO 9001:2015 Quality Management System 2. Promote continuous improvement within the organization 3. Participate in internal and external audits \\\\\Main Responsibilities and Functions:\\\\Monitor and maintain the Quality Management System in accordance with EN ISO 9001:2015\.\\Provide technical support and coordination to ensure products and processes are designed, implemented, and operated in compliance with regulatory requirements.\\Create, maintain, and retain Quality Management System documentation.\\Review and control the effectiveness of training programs.\\Create, manage, and track CAPAs and Non-Conformities.\\Propose and monitor the company's Quality Objectives, keeping Management informed about the Quality Management System's performance.\\Promote continuous improvement within the organization, ensuring the effectiveness of the Quality Management System and identifying opportunities for improvement and necessary changes.\\Participate in conducting and defending internal audits, including reviewing and following up on audit results.\\Participate in preparing, defending, and subsequently defining and monitoring action plans arising from external audits.\\Collaborate with other departments to ensure correct application of established procedures.\\Monitor, collect, and report quality-related data.\\\\Assigned Competencies:\\\\Assertive communication skills.\\Adaptability.\\Ability to work under regulatory requirements.\\Ability to work under tight deadlines.\\\\\\Job Profile:\\\\Bachelor's degree, Licentiate degree, Engineering degree, or higher.\\Knowledge and experience in quality management according to ISO 9001 standards.\\Knowledge of standards transition.\\Minimum 2 years of experience in Quality Technician roles.\\\\\