Quality Leader

Quality Leader
Empresa:

Welch Allyn De Mexico, S. De R.L. De C.V.


Quality Leader

Detalles de la oferta

Descripción y detalle de las actividades
ESSENTIAL DUTIES AND RESPONSIBILITIES
*Achieves quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.
*Meets quality assurance financial objectives by estimating requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.
*Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods.
*Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
*Assure overall site compliance to GMP, FDA QSR & ISO 13485.
*Acts as responsible for servicing Quality Assurance on validation (protocol writing and reporting), master planning of process transfer validation, DOE for process improvement, incoming quality inspection, test and reports, test design, destructive test reduction, among others.
*Responsible to direct the process/manufacturing engineers to understand the important steps of developing a detailed process flowchart, identifying CTQ variables (C&E diagram, C&E matrix FMEA), performing MSA (identify testing required, frequency, & gage R&R), understanding & eliminating special cause variation (CC & process capability), and then apply DOEs to verify the robustness (sensitivity) of the process & the products it produces.
*Develop and train personnel on: complaint investigations, CAPA real root cause fixing, pFMEA Prep., GMPs, GDPs, GLPs training and coaching, NCMR handling and solution, with a risk management approach.
Experiencia y requisitos
EDUCATION, EXPERIENCE, QUALIFICATIONS AND SKILLS:
*5-7 years of experience in the field of Quality Assurance.
*Minimum of 2 years of managerial experience.
*Proficient and knowledgeable in all areas related to the Quality Assurance function.
*Strong knowledge on quality tools (APQP, MSA, SPC, PPAP)
*Working knowledge of Statistical Process Control and PCB assembly process, results orientated attitude, achieve through team concept skills / activities.
*Strong knowledge of ISO-13485 standards and FDA.
CQA, CQE, CSSGB preferiblemente. CQA, CQE, CSSGB preferably.
*Bilingual: Oral and written communications in English intermediate.
Sitio web de la empresa:
http://www.hill-rom.com
Tipo de contrato:
Permanente
Nivel de estudios:
Permanente


Fuente: EmpleoNuevo


Área:

Requisitos

Técnico laboratorista clínico zona lincoln.

¿Te gusta la atención y servicio al paciente? ¿Cuentas con experiencia en toma de muestra y/o procesamiento de muestras biológicas? Solicitamos TÉCNICO...


Desde Salud Digna Para Todos, I.A.P. - Nuevo León

Publicado hace un mes

Supervisor de almacén.

"CASA CRAVIOTO empresa 100% mexicana con mas de 60 años en el mercado líder en su ramo busca talento ! Forma parte de nuestra familia como ""Supervisor de...


Desde Casa Cravioto - Estado de México

Publicado hace un mes

Trial attorney.

Profile: - Experience in Commercial and Civil Litigation - Law Degree Requirements: - Availability to travel - Driving license - Previous experience on Bank...


Desde Tbc De Mexico - San Luis Potosí

Publicado hace un mes

Gestor de cobranza en motocicleta ecatepec estado de méxico r1.

Banco Azteca solicita: GESTOR DE COBRANZA EN MOTOCICLETA Funciones: Recuperación de cartera Requisitos: Edad: 22 a 40 años Experiencia; De al menos 2 años en...


Desde Banco Azteca: División Cobranza - Estado de México

Publicado hace un mes