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Associate Principal Engineer

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Friendly, enthusiastic, an empathetic listener, creative problem solver, and a results-oriented Customer Service Representative with a proven record of integrity, efficiency, and strong work ethic. Experienced and skilled in handling diverse clientele, data entry, computer applications, POS systems/cash handling and office management. Team player with effective listening and communication skills, strong attention to detail, always willing to help, and a genuine desire to continue to learn and grow.

  I am an experienced professional seeking a position to utilize and grow my skills. Proven success in fast-paced office environments. Diligent team player with a strong aptitude for diverse clerical tasks and comprehensive staff support. Recognized for responsibility, punctuality, and high productivity in independent work.  

10+ Years of progressive experience in Medical Devices, Life science Health care, Labeling, Packaging, Web and graphic design skills Strong experience in the Medical Domain, EU MDR, IVDR, and Healthcare care products requirements Good experience in Gap assessment for standards, Analysis, and label Redlining Well-experience in Remediation, Proofing of artwork, labels, eIFU, IFUs & Manuals Updating Verification and Validation reports as per the WI or Procedure. Created redline for initial Artwork, labels, and IFUs with support of supporting documents like SDS, Shelf-life, Bill of material, Temperature, Rx Symbol data Gap Assessment - verification and identification of document number, catalog number & symbols Label Redlining - English Version (IFU, Unit Label, and Shipping Label) Label Artwork review of English and Non-English versions (IFU, Unit Label, and Shipping Label) Co-ordinated with external vendors for the other language translations Experience in Labeling and PLM Software using Easy Label, Viewpoint, Xiam, ADAPTIV, Agile, Windchill, WWL, Loftware, CDR, QB & Involved in executing Product artwork, labels, eIFU, IFUs & Manuals for records in Labeling tools. Involved in executing CR & COs, Under Change Notices for processing Artwork, and labels but not limited to creating red lines, Change Assessments, and Change Notice forms. Experience in working with cross-functional teams in Marketing, Regulatory, Medical Affairs, Regulatory Affairs, Quality Assurance, Engineering, Manufacturing, Legal and packaging. Conducting monthly governance calls with all internal and external stakeholders.

Virginia Rivera

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Web Developer I

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Bachelor of Arts - Information Technology

Working Towards Certificate in SQL

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Web Developer I

Bachelor of Arts - Information Technology

Working Towards Certificate in SQL

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