Head of Quality Assurance

Description

Head of Quality Assurance (Medical Devices) Position Purpose Lead, maintain, and optimize the Quality Management System (QMS) for the medical device manufacturing plant, ensuring strict compliance with current health regulations and institutional standards. The objective is to guarantee continuous improvement of the system, coordinate risk management, and supervise validation and audit processes to ensure operational integrity and regulatory compliance of products. Key Responsibilities * **QMS Governance and Continuous Improvement:** Direct, evaluate, and continuously improve the Quality Management System (QMS), implementing strategies that ensure its robustness and alignment with medical device manufacturing. * **Regulatory Surveillance (NOM\-241\):** Ensure strict compliance with the current NOM\-241\-SSA1 regulation and good manufacturing practices standards for medical devices, coordinating the handling, resolution, and follow-up of internal and external audits. * **Deviation and CAPA Management:** Supervise thorough root cause investigations for system deviations or nonconformities, ensuring the design, implementation, and effectiveness of corresponding corrective and preventive actions to prevent recurrence. * **Validation and Change Control:** Coordinate and validate the development of protocols, reports, and master validation plans (for processes, equipment, and critical systems), as well as provide technical oversight of change control and risk management. * **Document Control and Traceability:** Manage and safeguard the master documentation of the quality management area, ensuring full traceability of processes and materials in general. Required Profile * **Education:** Bachelor's degree or Engineering degree (with Professional License) in Chemical-Biological Sciences, Biochemistry (QFB, IQ), or related fields. * **Experience:** Minimum 3 to 5 years in leadership or supervisory roles within Quality Assurance or Quality Management, exclusively in the medical device sector or other regulated healthcare industries. * **Technical Competencies:** * In-depth knowledge and practical application of the **NOM\-241\-SSA1** regulation (Good Manufacturing Practices for Medical Devices). * Solid understanding of Quality Management Systems and ISO 13485 (desirable). * Experience managing CAPA systems, root cause analysis tools, and risk management (FMEA). * Training as an internal auditor and experience responding to COFEPRIS inspection visits. * Knowledge of production line and cleanroom/controlled environment validation. Employment Offer * **Compensation:** Statutory benefits \+ Grocery vouchers. * **Incentives:** Punctuality and attendance bonus. * **Benefits:** Free transportation service. * **Location:** Chalco, State of Mexico. * **Schedule:** Monday to Saturday. Salary: $19,800\.00 \- $25,507\.30 per month Benefits: * Transportation assistance or service * Company parking * Free parking * Company phone * Free uniforms * Additional vacation days or paid leave * Grocery vouchers Workplace: On-site employment