.EDUCATION and/or EXPERIENCEBachelor's degree in engineering (industrial, chemical, manufacturing, or any other related).And/or 3 years on QA/QC engineering work experience on QA/QC in medical device manufacturing processes such device assembly, injection molding or extrusion, preferable.Preferable ISO 13485 certified internal auditor.CPF-815 (11/23)Knowledge by school or work experience in risk Management analysis, FMEA - Control Plans management, statistical data analysis on Minitab, preferable, Test Method validation and GR&R execution, root cause analysis technics management, CAPA - Complaint - NCMR execution and management.Experience in Lean and Kaizen participation and execution is preferred.Negotiation and leadership skills.Advanced Computer skills (Minitab, Office, Word, Excel, Power Point, and/or Application Programs, Statistical Software, Databases. Etc.).SUMMARYQuality Engineer II is responsible for ensuring the safety and quality of our products and procedures through rigorous inspections, implementation of quality control measures, and identification of areas for improvement, collaborates with cross-functional teams to address quality issues, drive continuous improvement, and contribute to building high-quality products that exceed customer expectations. Quality Engineer possess a strong background in engineering or quality assurance, attention to detail, and a proactive mindset.ESSENTIAL JOB FUNCTIONSThis position can develop and manage Quality Control Technicians.Contribute to all cost saving and safety initiatives and related Continuous improvement programs.Generate and maintain process requirements, specifications, validation and confirming quality documents to assure product / component conformance.Develop and execute test method validations.Develop and maintain FMEA's and Control Plans.Perform, maintain, and sustain activities under QMS.Ensure that FI, CAPA, NMCRs and Customer complaints are addressing in a timely manner.Coordinate and/or contribute in DHRs processes.Document a quality alerts and coordinate investigations for NCMR, CAPA, FI and Customer Complaints.Generate a weekly and monthly reports using quality objectives.Provides support during audits and /or customer visits.Participate in the performance of the environmental management system in accordance with current roles and responsibilities.Support to all programs and initiatives in the areas of Hygiene, Safety, Environmental and Quality.Support for all programs and initiatives related to company's Internal Labor and securities regulations
