Descripción y detalle de las actividadesThe documentation coordinator is responsible for Control, maintenance & update of quality system documents. Responsibilities and Functions - Control, maintain & update all the documents related to the quality system, including standard procedures, work instructions, drawings, quality manual, etc. - Review submitted documents ensuring alignment with quality system and applicable regulatory requirements. - Support Change control management process, ensuring that any change affecting the QMS and approved appropriately. - Ensure the appropriated timing retention of defined quality records. - Collaborate in internal and external audits. - Ensure that only the latest version of any document is available in the point of use. Discarding as needed obsolete documents accordingly with the applicable procedures. - Support other assigned activities. - Collaborate NC CAPA related to findings derived from Internal or external audits. - Support quality system update and improvement project for document control. - Lead or participate in change control management meetings. - Collaborate as an expert in OnePLM Business system for the site. - Collaborate with the weekly metrics for ECN's & ECR's.Experiência y requisitosEducational Level and Special Training Required - High school minimum, bachelor's degree in engineering, or Business preferred. plus 3 to 5 years of experience in similar roll, including a minimum of three years in a medical manufacturing environment required. - GDP & six sigma GB certification preferred. - Considerable knowledge of quality systems for medical devices - Proficient in MS Office Suite (including Word, Excel and Power Point). Work Experience Required - 3 to 5 years of experience in similar roll, including a minimum of three years in a medical manufacturing environment required. - Knowledge of 21 CFR Part 820 and ISO 13485 highly preferred. Qualifications and Skills - Business acumen. - Communication. - Ethical practice. - CFR 820 and applicable regulatory requirements. - ISOOrganizaciónStrykerGiroManufactureraActividad principalManufactura de productos medicosNúmero de empleados750**Área** Calidad**Contrato** Permanente**Turno** Diurno**Jornada** Tiempo Completo**Estudios** Titulo Profesional**Sexo** Indistinto