Engineering Degree (preferably Manufacturing or Industrial Engineering) or equivalent
5 years in a formal supervisory role
GMP, ISO 9001, ISO 13485 21 CFR 820
Interpretation of customer specifications and implied requirements
Excellent verbal and written communication skills
Review, advise and continually improve the business management system (BMS) base on the requirements of ISO 9001:2015 International Quality Management System Requirements, ISO 13485 and FDA, 21CFR part 820. This includes developing the appropriate level of documentation (procedures, instructions, forms, etc.) to comply with the above mentioned standards.
Develop and lead continuous improvement ideas, projects and initiatives;
Drives culture change to instill focus on fact based management practices and the use of six sigma and other problem solving methodologies.
Conduct the organization Business Management System Review at regular interval to evaluate the suitability, adequacy and effectiveness of the BSM.
Interfaces with purchasing and engineering in the qualification of new suppliers and the evaluation of current suppliers.
Established the consistent use of quality management tools.
Participates in product quality planning activities and approve process validations to ensure the successful introduction of new products equipment and processes.
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2 ó más años de experiencia Inglés: dominio del idioma (nativo ó 2do. idioma) Requiere residencia actual en República Dominicana