Oceanside, CA, 92057
... Governance & Validation Root Cause Analysis, CAPA & Fault Analysis KPI Development & Performance Optimization Lean Six Sigma & Continuous Improvement Cross-Functional Team Leadership Regulatory Audits & Gap Assessments PROFESSIONAL EXPERIENCE G.L. ...
- Jan 28
Chennai, Tamil Nadu, India
... 05/2013 – 10/2015 Chennai, India QA/QC Engineer Sarang Auto Parts Private Limited •Conducted inspections and CAPA reporting for non-conforming materials across production lines. •Led APQP and PPAP development, and verified ECRs (Engineering Change ...
- Jan 27
Stone Mountain, GA
... & Metrology (CMM, fixture design, measurement systems) ISO 9001 Quality Management Systems Corrective & Preventive Action (CAPA, Root Cause Analysis, 8D) Injection Molding, Automated Assembly, Metal Fabrication & Welding Cross-Functional Technical ...
- Jan 26
Las Vegas, NV
... Actions (CAPA) / Medical Imaging Quality System / Clinical Research / Verification and Validation (V&V) A highly entrepreneurial executive who runs and grows leading-edge technology firms, with 30 years of global medical device experience. ...
- Jan 25
Fairborn, OH
... ●Integrated ETQ QMS (or similar QMS tools) with SAP QM to enable seamless exchange of quality data, non-conformance records, and corrective/preventive actions (CAPA). ●Worked extensively with Enhancements (BADIs, User Exits, Customer Exits) and the ...
- Jan 23
Alpharetta, GA
... Quality Control (QC) Inspection Acceptable Quality Level (AQL) Microscope Inspection Instron Calibration Food Allergen testing CAPA First Article Inspection EDUCATION & CREDENTIALS Gwinnett Tech- Radio Logic Technology, 1999-2000 Lawrenceville, GA ...
- Jan 21
Durham, NC
... Submissions MHRA Submissions IND / CTA Submissions IRB Submissions Safety Evaluations & Risk Assessments Quality Systems CAPA & Deviations Clinical Trial Support Clinical Trial Documentation Clinical Trial Data Management Study Management Clinical ...
- Jan 21
Ocala, FL
... Management Representative and Official Correspondent responsible for leading Management Reviews, FDA Registrations/Reporting, CAPA Review Boards and Notified Body Audits. •Supplier Controls (Approval, Audits & Monitoring) •Quality Systems Documents ...
- Jan 21
Durban, KwaZulu-Natal, South Africa
... as and when requested by Technical Manager • Update database on all IP platforms • Responsible for the management of the CAPA process • Update and maintain auditors competencies • Maintenance of Incident Management • Review QA department invoices ...
- Jan 19
Cape Coral, FL
... provide sign-off for Regulatory Research and track regulatory submissions using Liquent/InSight Summarize Annual Reports - backlog Certifications CAPA Professional Certification (2014) from CfPIE Active Ingredient and Drug Specifications ...
- Jan 18