Noel Lopez Email & Phone Number

Durham, North Carolina, Us

Varennes, Quebec, Ca

Charlotte, North Carolina, Us

• Worked as system administrator for IQVIA SmartSolve and EtQ Reliance, closed more than 90 incidents.• Built and ran reports to determine impact, extent, and frequency of bugs. • Worked with software vendors to ensure business needs were met. Assisted with upgrades and enhancements.

Kalamazoo, Mi, Us

• Developed and performed weekly smoke tests on the latest nightly builds of the software application.• Reviewed, approved, and provided feedback on software requirements and functional design descriptions.• Wrote test cases based on software requirements and design documents.• Trained 7 individuals on the use of the joint replacement software application and the execution of smoke tests.• Identified and ensured resolution of 52 defects into JIRA.

Inchinnan, Renfrewshire, Scotland, Gb

• Gathered business requirements for and supported/executed implementation/enhancements/configurations of IQVIA SmartSolve and EtQ Reliance electronic Quality Management System software applications and their reports• Worked as system administrator providing technical support for SmartSolve and Reliance • Became a subject matter expert on software requirements risk assessment, user acceptance testing, and validation and performed gap assessment as part of remediation to align with new FDA regulations

Weston, Florida, Us

• Performed quality control testing on manufactured and in-coming raw materials product to determine conformance with acceptance criteria• In charge of accelerated/real time stability testing on finished product and pre-market validation testing on new products

As part of a team of 6 biomedical engineers, used inventory control software system to add new equipment to inventory and perform verification of all biomedical equipment inventory (a total of 12,000 pieces of equipment) at University of Miami Hospital. Identified issues with malfunctioning equipment and managed spreadsheet with equipment status and information to optimize repair/preventative maintenance scheduling. Kept department heads and directors updated on progress through verbal reports, emails, and service paperwork.

Miami Lakes, Fl, Us

• Participated in a voluntary recall of Precise Pro Stent System in alignment with Code of Federal Regulations• Interfaced directly with customers and sales people to communicate the recall effort by phone, email, and letter • Served as the point of contact for customers seeking service or more information about the recall• Used good documentation practices in recall documentation and records control to prevent any gaps in content• Obtained field action contact information from all customers and maintained spreadsheets of contact data for future incidents in compliance with FDA regulations• In charge of visual inspection of recalled devices to test suitability for salvage• Assisted in organization and migration of audit records (internal, external, CAPA, supplier) from one electronic document control system to another.