Product Quality Engineer | Otay
and problem-solving methodologies, including: 8 D, 5 Why Analysis, FMEA, SPC, MSA, Control Plans, CAPA. Experience with supplier...
and problem-solving methodologies, including: 8 D, 5 Why Analysis, FMEA, SPC, MSA, Control Plans, CAPA. Experience with supplier...
assessments preferred. Strong knowledge of FDA Quality System Regulations (21 CFR Part 820 / QMSR), ISO , CAPA, Supplier Quality...
and Preventive Action (CAPA), Demand Forecasting, Demand Planning, Developing Others, Distribution Management, Inclusive Leadership...
to address failures and/or trends reported by customers.Investigations/Action PlansLeads/supports CAPA investigations to address...
and other risk management tools. Investigate process deviations, nonconformances, customer complaints, and CAPA activities. Support... with CAPA, nonconformance investigations, and root cause analysis methodologies. Strong project management and cross-functional...
and internal standards.You will analyze quality data, lead CAPA activities, support NPI, and collaborate with engineering...
quality standards.The role emphasizes CAPA investigations, risk analyses, and participation in continuous improvement...
and oversight for key Quality System activities, including audits, Corrective and Preventive Actions (CAPA), complaints... requirements, industry standards, and company policies and procedures.Provide oversight and governance for CAPA, complaints...
. Investigate quality issues, perform root cause analysis (RCA), and implement corrective and preventive actions (CAPA...
and Preventive Action (CAPA), Demand Forecasting, Demand Planning, Developing Others, Distribution Management, Inclusive Leadership...