Description
Summary Over 20 years' experience in a medical device industry. Out of the box thinker who is self-managed, self-motivated, results oriented, quality conscious, problem solver, with ability to multi-task, make decisions, resolve issues, meet deadlines learn new skills and communicate effectively at all levels of the business. Experienced in the following: Receiving Inspection, Final inspection, internal auditing and supplier auditing and engineering activities, GD & T, Creating Inspection plans, approving plans, first articles, and verification of certifications ROHs compliance and supplier risk assessment for technical file Quality engineering activities to include: verification and validation (IQ, OQ, PQ), peer review for Quality system documents, design documents, process improvements, compliance and disposition of nonconforming materials. Supplier Quality engineering activities to include SCARs, supplier quality issue resolution, supplier qualification, supplier scorecard development, part qualification and continuous improvement. CAPA investigations and risk assessments Document change control of Quality System documents, BOM, manufacturing documents, drawings, Quality Plans, protocols and reports Project management for business systems changes, process improvement projects and label localization projects Process improvement projects using Lean Manufacturing Methodology UDI implementation for Class II LS medical devices SAP, Track wise, Microsoft applications
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