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.
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
|Área||Control de Calidad|