Middletown, DE
... CORE COMPETENCIES Computerized System Validation (CSV), CAPA / Quality Systems, Data Integrity & Compliance (ALCOA+), USP <1058> AIQ, USP/EP/JP/ICH, Risk Assessment / Gap Analysis, Product & Service Marketing, FDA / ISO Regulatory Compliance, NPI ...
- Nov 29
Pune, Maharashtra, India
... Demonstrated expertise in ISO 9001, IATF 16949, and core quality tools including APQP, PPAP, PFMEA, MSA, SPC, and CAPA, with a proven record of driving defect reduction and operational excellence through Lean Six Sigma methodologies. Strong ...
- Nov 28
Salem, WI
... a.Supported internal/external quality audits b.Identified and documented deviations and non conformance to SOPs c.Determined CAPA and monitored results ● Systems used: SAP, iREP, Kiteworks, Clarify, Javlin, Microsoft Office Suite (Excel, Word, ...
- Nov 28
West Roxbury, MA
... SKILLS Regulatory & Quality Systems: FDA 510(k), PMA, IND/NDA/BLA/ANDA, 21 CFR 820, ISO 13485, ISO 14971, EU MDR, ICH Guidelines, Clinical Trial Regulation, PMS, CAPA, Root Cause Analysis, QSR Audits, Global Policy Monitoring (FDA, EMA, PMDA, APAC, ...
- Nov 24
Illinois
... attempt PPAP, APQP, FPA acceptance record Support Sigma Tron Medical device division located union city in internal and external CAPA as team leader -involves root cause analysis, action plan to prevent defects Worked on permanent 8-D preventative ...
- Nov 24
Anaheim, CA
... Time to Work divided by Customer Demands will give piece work time (min/piece) Setup of Lab Equipment periodic reviews including calibration and specifications updates Investigated equipment for a Process Deviation and generated CAPA reports. ...
- Nov 24
Tabuk, Saudi Arabia
... Proven track record of delivering quality excellence, improving Project Quality Index (PQI) to 90%+, embedding risk-based methodologies (FMEA, RCA, CAPA), and leading organization-wide quality transformation initiatives. Skilled in multidisciplinary ...
- Nov 22
United States
... CORE COMPETENCIES • Manual QA Testing Leadership • QA Strategy Development & Ownership • Regression, Integration & Performance Testing • SDLC, Agile QA Integration • Documentation, SOPs & CAPA • Defect and Recall Reporting & Root Cause Analysis • ...
- Nov 21
San Antonio, TX
... 3M (formally, Acelity / KCI) Designed MS Word test document templates that are compliant with regulatory standards and resilient to audit scrutiny by the Federal Drug Administration (FDA) using Corrective and Preventative Action (CAPA) initiatives ...
- Nov 21
Dayton, OH
... Visual Management Systems, Procurement Strategies, Root Cause Corrective Action (RCCA), Corrective and Preventive Action (CAPA), Statistical Methods for Management Decisions, Manufacturing Quality Assurance, Microeconomics, Mathematical Modeling, ...
- Nov 21