Management Quality

Purpose:

Responsible for managing, developing, implementing, maintaining, and measuring the effectiveness of the Company's Quality System and applicable Certifications, ensuring the monitoring of its effectiveness through periodic reviews of Quality metrics to ensure they meet established requirements, as well as the company's quality policies .

Functions:

Directs the administration of the Quality System and applicable certification systems, including the development, maintenance, and updating of quality policies, procedures, methodologies, and tools.

Implements quality policies, procedures, methodologies, and tools that ensure compliance with product specifications and quality system requirements. Acts as the primary representative and contact on quality issues at the plant level with Corporate (USA) and sister plants (Italy/Germany).

Coordinates preparation activities for External Audits at the company’s manufacturing sites.

Reports to senior management on the performance of the Quality System. Coordinates the preparation of meetings and quality reports for the review of key performance indicators.

Management Representative to Foreign Regulatory Agencies and Health Representative to Mexican Quality Certification Agencies.

Creates and communicates quality policies and objectives, focusing on meeting customer and corporate needs.

Establishes and ensures, in conjunction with senior management, Quality objectives and ensures their compliance and performance.

Coordinates and ensures compliance with customer requirements and the effectiveness of preventive/corrective actions.

Coordinates compliance with inspection procedures (raw materials, processes, and/or final product) to ensure quality requirements are met. Responsible for developing and analyzing process performance through the monitoring and analysis of statistical data and acceptance criteria. Responsible for developing and managing the plant’s quality budget to meet all annual financial requirements.

Responsible for selecting, training, developing, motivating, and acting as a facilitator for the team as part of the Talent Management process.

Responsible for the development, communication, and monitoring of Quality Strategic Planning.

Experiencie : Minimum of 7 years in Quality, preferably in the Medical Industry. Including at least 5 years in supervisory roles. Senior level: 10 years in the medical industry, with at least 7 years in supervision

Education: Bachelor’s degree in Industrial Engineering, Chemical Engineering, Mechanical Engineering, Electrical Engineering, or a related field. Master’s degree or specialization in engineering and/or Quality Systems.

Hard skills: Advanced knowledge of medical industry regulations and standards (ISO 13485-2016, MDSAP, FDA QSRs, EU MDR, CANADA, NOM-241). Advanced knowledge in quality engineering: Handling of non-conforming products Process control (MFG) Data analysis and monitoring Knowledge of root cause analysis tools (8D methodology, 5 Whys, DMAIC, etc.) Proficiency in Quality Management and Administration Tools. Risk Management in Medical Devices (e.g., ISO 14971). Knowledge of Strategic Planning process stages. Application of continuous improvement tools such as Lean Manufacturing / Six Sigma. Understanding of medical industry validation cycles (Design, Validation, and Monitoring of Processes). Management and Control of suppliers and raw materials. Proficiency in Microsoft Office Suite. Knowledge of statistical tools. Lead Auditor ISO 13485-2016. Certified Quality Manager by the American Society for Quality (ASQ).