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Seasoned Medical Device Executive and Growth Leader

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

ABAP Fiori Developer with RAP & SAP BTP Expertise

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

Quality Assurance & Validation Specialist with GMP/GLP Expertise

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

Pharmacovigilance and Regulatory Operations Expert

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

Senior Quality Engineer Med Device & Manufacturing

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

Office Manager with Cross-Sector Experience

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

Regulatory Affairs Expert 25+ Years in Pharma Regulatory

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

S

Indianapolis, IN
... • Collaborated with cross-functional teams and quality engineers to strengthen corrective and preventive action (CAPA) practices. • Developed skills in quality systems management, regulatory compliance, and data-driven problem solving. PROJECT ... - Jan 18

Quality Assurance Leader Medical Devices & ISO Standards

Porter, TX
... Proven hands-on experience with CAPA, Management Reviews, Process Controls, Equipment and Process Validations, Internal Audits, Risk Analysis, Supplier Quality, Training, Design Assurance support and non-conformance investigations and corrective ... - Jan 17

Client Support-Oriented Engineering Leader

Florence, KY
... suppliers Use various RCA techniques to lead all CAPA projects Thru implementation of SPC, assist the plant operations in predictable manufacturing and process control Improved external PPM for top customers from 1800 to 50 (customer target 500); ... - Jan 17
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