MATERIALS QUALITY MANAGER - BIOFINE

Description

Job Summary: Lead, ensure, and control the quality of raw materials and components, guaranteeing strict compliance with regulations and minimizing risk in the production process. Key Highlights: 1. Responsible for ensuring the conformity and performance of all materials. 2. Lead the quality control of raw materials and components. 3. Contribute to improving patient care worldwide. At Fresenius Medical Care, we are global leaders in renal care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver innovative, high-quality products, services, and care across the entire health journey. Guided by our vision — *“Creating a future worth living. For patients. Around the world. Every day.”* — we act with purpose and compassion, supported by a global team of more than 110\.000 colleagues. At our Bogotá plant in Colombia, we specialize in the production and distribution of a broad range of high-quality products essential for dialysis therapy and patient care. We manufacture HD and PD solutions, disposables, intravenous solutions, and Biofine empty bags. Additionally, we distribute the dialysis portfolio, including pharmaceuticals, dialyzers, blood lines, and dialysis machines. The Bogotá team plays a pivotal role in Fresenius Medical Care’s commitment to improving patient care worldwide. Join our passionate team and be part of this global impact! Our values guide how we work: * We care for our patients, for each other, and for our communities. * We connect teams and borders to deliver excellence together. * We commit to doing things right — growing with purpose and leading renal care with integrity and innovation. **MATERIALS QUALITY MANAGER \- BIOFINE** **Position Summary** Lead, ensure, and control the quality of all raw materials, packaging materials, and components entering the plant and those manufactured at the plant (bags), guaranteeing strict compliance with applicable regulations (cGMP/GMP and regulatory requirements such as FDA/INVIMA). Responsible for ensuring the conformity and performance of all materials, minimizing risk in the production process, and ensuring the safety of the final product. **Key Responsibilities:** * Responsible for approving and/or rejecting raw materials, materials, and medical devices after reviewing relevant test reports and in accordance with current specifications, to ensure that raw materials, materials, and medical devices meet required quality standards. * Verify that sampling and testing of raw materials, materials, and medical devices are performed in accordance with current specifications and procedures. * Responsible for developing and/or reviewing specifications, sampling procedures, analytical methods, and other documents required to support routine laboratory activities for materials and Biofine. * Verify timely entry into the SAP system of analysis data for raw materials, materials, and medical devices, and issue corresponding quality assessments. * Verify development and consistency of specifications, sampling procedures, analytical methods, and other documents required to support routine departmental activities. * Review Biofine and Overwrap batch records and release materials. * Ensure maintenance, calibration, and qualification of laboratory instruments and/or equipment. * Supplier qualification and maintenance of supplier records in the SME system of SQM (TW). * Handling supplier complaints. * Responsible for ensuring initial and ongoing training of personnel under supervision, aligned with their respective roles. * Responsible for meeting the laboratory’s monthly and annual budget through monthly procurement and consumption activities subject to inventory management. * Submit purchase requests, quotations, and invoice entries for area requirements. **Qualifications, Experience, Knowledge, and Skills** * Bachelor’s degree in Pharmaceutical Chemistry, Chemistry, Chemical Engineering, or related field. * Minimum 2 years of experience in Quality and Audit Management. * Technical knowledge of Quality Systems (cGMP, GLP) and medical devices. * Training in leadership and communication. * Proficiency in Microsoft Office suite (Word, Excel, PowerPoint). * Knowledge of Minitab (desirable). * Knowledge of SAP. * Intermediate English. * + Work location: Via Siberia Funza, Intexzona Free Trade Zone; Monday–Friday, on-site. **Our Offer to You:** There is much to discover at Fresenius Medical Care — regardless of your area of expertise or level of experience — all focused on your professional development. Whether on the front line or behind the scenes, your contribution helps make increasingly better medicine available to a growing number of people worldwide. * Individualized opportunities for career planning and autonomous professional development. * A corporate culture that fosters innovative thinking — so that together we find the best solution, not just the fastest one. * A large number of dedicated individuals with diverse competencies, talents, and experiences. * The benefits of a successful global corporation, combined with the collaborative culture of a mid-sized company.