quality system compliance , traceability , QA QC Coordination, Document Control, QMS documentation, 8D, Capa, Rca, Iso 9001, Continuous Improvement, As9100, audits, ISO13485, corrective actions

Iso 13485, 8D, Capa, Rca, Iso 9001, As9100, audits, Qms

Quality Management Systems, GMP and GDP compliance, Product complaint handling, Quality risk management, Pharmacovigilance, Change Control, Quality Agreements, Recall management, CAPA and deviation management

batch records , Cgmp, Working with CMOs and external manufacturing partners, CAPA activities, Quality input to risk assessments, Sops, Change controls, Deviations, Investigations and root-cause analyses, Risk mitigation plans, cGTP

statistical process control (SPC), calibration of test measuring equipment, inspection test plans, Data Analysis, Risk Assessment, 6-Sigma Black Belt, quality assurance plans, Iso 9001, external audits, Ohsas, Lean Manufacturing, quality metrics, root-cause analysis

8d problem solving , Sql, Excel, Jmp, Yield Analysis, IATF 16949, Iso 9001, Capa, Pfmea, Fmea, Reliability Engineering, Minitab