Quality Coordinator

Medical Devices Quality Coordinator Area: Quality Reports to: General Director Responsible Sanitary Officer Job type: Fees Objective of the position Coordinate and ensure compliance with the Quality Management System (QMS) in accordance with NOM-241-SSA1-2021 and other regulatory provisions applicable to medical devices in Mexico, ensuring that products meet safety, efficacy, and quality requirements throughout their life cycle. Main responsibilities: * Develop, implement, and maintain the QMS, ensuring its continuous improvement. * Ensure compliance with NOM-241-SSA1-2021 and other applicable regulations. * Conduct internal audits and follow up on corrective and preventive actions. * Manage and investigate non-conformities, complaints, and incidents. * Oversee product validation and verification processes. * Prepare and maintain quality documentation, including procedures, instructions, and records. * Provide training on quality topics to personnel. * Support regulatory affairs activities related to quality. * Establish and maintain relationships with suppliers to ensure the quality of purchased products and services. * Monitor the performance of the QMS through key performance indicators (KPIs). * Collaborate with other departments to ensure the quality of products and processes. * Keep abreast of changes in regulations and standards applicable to medical devices. Requirements: * Bachelor's degree in a related field (e.g., Pharmacy, Chemistry, Biology, Engineering). * Minimum 3 years of experience in quality control of medical devices. * In-depth knowledge of NOM-241-SSA1-2021 and other relevant regulations. * Experience in conducting internal audits and managing non-conformities. * Knowledge of validation and verification processes. * Proficiency in the use of quality management tools. * Excellent communication, organizational, and problem-solving skills. * Ability to work independently and as part of a team. Desired skills: * Experience with ISO 13485. * Knowledge of risk management methodologies. * Experience with statistical process control. We offer: * Competitive salary. * Opportunity for professional development. * Work environment with growth potential.