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About this Candidate
DAVRON Report for this Quality Engineer / Project Manager:
- Experienced in process, design, and software validation with deep compliance knowledge of FDA, ISO 13485, ISO 14971, EU MDR/IVDR, and 21 CFR Part 11 for pharmaceutical and medical device environments
- Skilled in managing validation lifecycles including IQ/OQ/PQ protocols, SOP development, risk management, CAPA systems, and design control for Class I–III medical devices
- Proficient in validating ERP, MES, and custom systems including Documentum, Siebel, Oracle, and SAP, as well as lab systems such as LabWare LIMS and Empower
- Proven track record in cross-functional project leadership, audit readiness, and quality system development with consistent results of zero non-conformances during regulatory audits
- Strong technical writing and documentation expertise with experience authoring over 1,000 SOPs and supporting documentation across GxP environments and international compliance standards
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