SUMMARY
R&D Sr. Quality Engineer whose qualifications include a MBA & a degree in Industrial Engineering & Supply Chain Management. Looking to attain a career opportunity in the fields of Quality Engineering and/or Research & Development. Eight years of Quality & Engineering experience within Consumer Product Goods, Healthcare & Plastic Injection Molding Industries. Two years of experience in the Healthcare Industry: FDA audits, verification/validation activities & CAPA champion. Eight years of experience with ISO audits: Internal Lead Auditor or audited by an external source. Three years of heavy involvement in New Product Development. Covering all areas related to Quality, from product inception to product launch. Including interaction with Marketing, Design, Tooling, Automation & Production groups as well as Tooling Suppliers. In summary, eight years of exceptional quality & engineering experience from product concept all the way through to commercialization as well as continuous improvement after product launch.
EXPERIENCE
Lean Manufacturing, Six Sigma Methodology, DOE, Regulatory Compliance, QSR ISO 13485, QMS ISO 9001, CAPA, FDA Audits, FMEA, CP, Verification, Qualification, Validation, Process Capability & Project Management of products from inception to product launch.
PROFESSIONAL ADVANCEMENT
NEW PRODUCT DEVELOPMENT
Led the Quality Initiatives of products in development stage, products being released to market (mass production stage), as well as mature products. Assisted the Product Development Team. Determined customer requirements based on focus groups led by marketing, translated requirements into product specifications for the design team & qualified vendors for the tooling team based on CTQ’s. Assisted in molds, as well as systems & processes validations. Developed quality standards based on actual consumer use & EOL expectations.
HEALTHCARE INDUSTRY
Led Supplier CAR’s & Internal CAPA’s. Assisted MRB by providing material dispositions. Developed process verification & validation (IQ, OQ, PQ) protocols. Actively participated in Shingijutsu events & Cost Improvement Projects. Led an assembly line lean...
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