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).
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We care about sharing information and experiences as this helps us learn from our mistakes and each other. We tackle challenges together by reaching out to colleagues both near and far. We communicate openly.
We challenge the status quo and show interest in what happens around us. We ask questions to clearly understand what needs to be done and take ownership of the results.
We live up to our own expectations, show respect and lead by example. We act with integrity and in line with our standards every day.
We make things better today than they were yesterday. We pitch ideas on how to improve and innovate.
Empowering people. Advancing care. Inspiring with our purpose and values.
Everything we do here is about making people’s lives better, simpler and longer. Our teams work cross-functionally to reproduce the complex function of kidneys with treatments that meet high quality standards, improve clinical outcomes, and are sustainable and compliant. Internally, we promote diversity and inclusion as key elements of a positive, supportive work environment. Our values support our mission to develop high quality products and services, to have a positive impact on the health and wellbeing of patients, and to lead Fresenius Medical Care towards a successful, sustainable future.
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