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Online Resumes with "Documentation Data Control Management CFR21 Part 11 Compliant"
QA/RA Manager / Senior Quality Engineer
I am seeking a like position with both challenge and room for unique contributions my background and experience can bring. I am willing to relocate for the right opportunity.
Ideal Companies: New Start-ups
Tags for this Online Resume: Company-Wide Quality Systems design, development & Certification to FDA/QSR, ISO13485 and all other associated regulatory requirements in both domestic and international markets for a broad range of Class I, II & III Medical Devices, Documentation/Data Control Management – CFR21 Part 11 Compliant, Develop/Manage Contractor-Supplier-Customer Partnerships (Internal & External) for Custom & Off-the-Shelf materials and components fabrication, assembly, sterilization, packaging, storage & distribution from Domestic & Global resources, Strategic Planning for Products / Budgets & P/L Responsibility, Lead Auditor for External QS Audits / Develop & Manage Internal Audit Programs, Post Market Surveillance Management, including Customer Service & Compliant Handling, for Continuous Improvement Program
