Summary: This role is responsible for maintaining the company's quality system, ensuring compliance with regulations, and driving continuous improvement initiatives. Highlights: 1. Lead compliance with FDA, ISO, and Canadian Regulations. 2. Drive continuous improvement through quality projects. 3. Manage and optimize resources for quality objectives. **Job Description** **GENERAL OBJECTIVE:** This role will work closely with the Quality Director, Quality Manager, and Direct reports to ensure the correct and complete Quality Transition Plan and functionality of Medline RCI Hudson. Responsible for maintaining the company's quality system and supporting compliance with FDA, ISO, and Canadian Regulations, and ensuring compliance with quality objectives. Work with management levels at the site to establish goals to achieve a strategic business plan. **RESPONSABILITIES / FUNCTIONS:** * Ensure compliance with previously determined quality objectives. * Maintains Continuous Improvement through quality projects in the assigned area. * Manages and optimizes the necessary resources for the assigned area. * Reports the weekly and monthly results in the work area to the multidisciplinary group. * Reviews and improves manufacturing and inspection procedures based on improvement. * Control and improve the training process for inspectors, leaders, and supervisors. * Establishes development metrics in the positions of supervisors, leaders, and inspectors. * Verify and update Documents in ETQ. Reliance. * Establishes the acceptability of the processes and confirms the correct inspection process in the manufacturing lines. * Authorizes substitutions and deviations generated during the assembly process. * Attends room/area results control meetings with the multidisciplinary group. * Conducts investigations of customer complaints directly related to manufacturing. * Produces Quality Cup and Line Bonus reports according to the established policies. * Generate and Implement Improvement Ideas * Participate on MKO’s Implementation strategies **Communications:*** Implement simple ideas for continuous improvement * Maintains effective communication by mail with personnel in charge * Gives support in training/talks to inspectors, leaders, and supervisors. * Maintains effective communication with adjacent departments. **Employee Relationship:*** Maintains a pleasant work environment with co\-workers from the same and different departments. * Guides and provides solutions to doubts related to the quality system. * Manage processes and training for inspectors, leaders, and supervisors. **Health and Safety:*** Follow the safety rules when you are inside the PDM facilities. * Monitor and report risk situations in your work area. * Evaluates the work area and provide improvement ideas for clean/safe and ergonomic work. **Quality Systems:*** Ensure compliance with quality objectives and maintain the Continuous Improvement of the Quality System. * Establish \& maintain an Internal Audit process to ensure that the Quality Management System complies with all applicable regulations. * Develop Internal Auditors of the Quality Management System. * Prepare required translations of controlled documentation of the Quality Management System if required. * Lead cross\-functional work teams appointed by the company's management. * Manage the training of personnel involved in the quality assurance system. * Communicate customer complaints to all personnel related to the quality system. * Maintain the quality of the system documentation system. * Participate in the different programs of the plant as applicable. * Responsible for CAPA Approval in Medline RCI Hudson. * Provide support in planning and conducting the Operational Strategy "Quality Week." * Manage the Provider Alert Program. * Serve as 5's Program Auditor. **EDUCATION/ACADEMIC REQUIREMENTS:****Experience:*** Minimum 5 year’s experience in a similar position. * Experience and knowledge of more than 5 years in Manufacture. **Academic requierements:*** Bachelor's Degree / Industrial Engineering, Industrial Engineering, Business Administration or related careers. * Postgraduate studies in related field is desirable. **Technical Skills*** Bilingual: English 80%. Min. * Extensive knowledge in Quality Management Systems. * Knowledge of Continuous Improvement Methodologies and Lean Manufacturing. * Knowledge of Software; Microsoft Office (Word, Excel, PowerPoint, Outlook), * MS\-Project, MS\-Vision, Internet and Information Systems for ERP / AS400 generation. **Interpersonal Skills:*** Leadership. * Responsible. * Communication (All levels). * Public speaking. * Proactivity. * Initiative * Results Oriented. * People Oriented. * Decision Making. * Critical Thinking * Conflict Resolution. * High ethical levels and decision\-making focused on corporate values. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.