QA/RA Lead
Amphenol CMT - Critical Medical Technologies
Quality Assurance & Regulatory Affairs ensure that the company adheres to all applicable laws and regulations, including health and safety, environmental and customer requirements, manage and coordinate internal and external and supplier audits to be in compliance with national, international (if applicable) and internal regulations, ensures the correct implementation of Quality Management System, which includes supervises and coordinates the quality resources as required on the different QA/RA areas, ensuring that the processes and product are following the specifications and standards stablished by customer and the organization. • Bachelor’s Degree in Engineering (industrial, chemical, mechanical, or related). • Ideal to have 3-5 years of experience in medical device manufacturing processes. • ISO 13485 certified internal auditor. • Knowledge QSR/JPAL/CE Mark requirements • Risk Management analysis. • Advance Computer skills (Minitab, Office, Word, Excel, Power Point, and/or Application Programs, Statistical Software, Databases.Etc.). • Ideal to have advanced training skills. • Knowledge of National and International Medical Manufacturing Quality Standards. • Certification Desirable (Green Belt, Certified Lead Auditor, Certified Quality Engineer, or any other related.) • Knowledge of ISO 14001 Environmental management System • Leadership skills.
Hace 8 horas en Tijuana
