Takara Mosquera Phone: 786-***-****

Pembroke Pines, FL 33027 actcm5@r.postjobfree.com

QUALIFICATIONS

Professional, degreed Engineer with over 8 years’ experience performing a variety of Engineering, Quality, and Project Management tasks.

Excellent leadership, project management, and interpersonal skills with a reputation for completing challenging assignments on time. Quality conscious, detailed, results oriented, and fast learner. Experienced in:

Management and execution of client activities complied with all applicable government regulations.

Management of projects in a highly regulated environment.

Manage multiple projects concurrently trough utilization of project management best practice to ensure customer time and quality requirements are met.

Development and execution of IQs, OQs, PQs, and TMVs.

Managed completion and executed CAPAs.

21 CFR 806 (c), and 1002 submittals.

Training of process, functions, and work instructions to client(s) managers, lead, engineers, maintained, and suppliers.

FDA audit, backroom.

PROFESSIONAL EXPERIENCE

Philips Healthcare – Highland Heights, OH Feb 2015 – Sep 2015

Quality & Regulatory (Q&R) Project Manager for Post Market Surveillance Contractor

Developed and managed project plans and teams (consisting of Engineers, Clinician, SME, Supplier, and various other group) for multiple Computed Tomography (CT) and Advanced Molecular Imaging (AMI) field actions. Provide strategic input and technical guidance to team. Oversee projects completion and on schedule. Review and recommended changes to maintain quality and regulatory compliance.

Initiate, manage, and provide guidance for field action engineering investigations, so to properly assess the risk of patient harm and develop HHE.

Provide guidance on Root-Cause Analysis using problem solving methodologies; Brainstorming, 5-Whys, etc.

Developed HHE, Field Action Notices, Customer Information Notification, Product Safety Committee (PSC) request, presentations (for committee, executive management and Key Markets), Field Change Orders, Risk Analysis, Consignee List, Field Actions, etc…

Execute Corrective Action in field and support Preventive Action as end to end owner of Field Change Orders.

Lead and build multi-disciplinary project teams, comprising representatives from relevant functions.

Developed and maintained MS Project plan for each PSC and field action, detailing the required work breakdown, tasks, estimated effort and milestone/target dates.

Coordinate communication to Key Marketers Service Organization and Sr. Executive Management.

Compile, prepare, review and submit regulatory submission to authorities (21 CFR 806 or 1002), as well as those for other affected Competent Authorities.

DePuy Synthes, Johnson and Jonson – West Chester, PA Nov 2013-Dec 2014

Recall Investigation Engineer, Quality Assurance for Post Market Surveillance Contractor

Manage and develop packages for FDA submission (pulling manufacturing logs, HHEs, CAPAs, etc Assist with FDA audits. Manage Field Action activity as a result of Quality Review Boards, Health and Hazard Evaluations. Manage Field Action meetings and coordinated communication of recall activities throughout regions and countries. Ensure all field action documentation is maintained and up to date per requirements identified in SOP’s, and the compliance requirement are up to date.

Manage and develop for FDA submission packages (pulling manufacturing logs, HHEs, CAPAs, Complaints, MDRs, QRBs, etc.).

Ensure all field action documentation is maintained and up to date per SOP requirements.

Work with Recall Execution, Complaints, and CAPA Teams to review and verify CAPAs, MDRs, HHEs, PRAs, and QRB minutes/slides.

Draft and assisted with development of HHE.

Reviewed and monitored monthly status of CAPAs to provide reports for management review.

Provide support for FDA and EU audits.

Assist with preparation of FDA and EU document submissions.

Hospira – Lake Forest, IL Aug 2013-Nov 2013

Quality Assurance Engineer II Contractor

Provided support with QSR (GMPs) per 21 CFR 820 and requirements of EN ISO 13485, 13485 and 9001:2008, Recall, evaluation for 21 CFR Part 806/Filed Action and documentation, evaluation Product Notification Assessment (PNA)/510(K) Decision, and Verification and Validation, and audits.

Provided support with QSR (GMPs) per 21 CFR 820 and requirements of EN ISO 13485, 13485 and 9001:2008, Recall, evaluation for 21 CFR Part 806/Filed Action and documentation, evaluation Product Notification Assessment (PNA)/510(K) Decision, and Verification and Validation, and audits.

Developed forms and instructions for recording, evaluating, and reporting quality and reliability data.

Established and improved product/process quality through team based problem solving efforts.

Provided compliance and quality system support.

Assisted in the development and implementation of new quality systems.

Zimmer Inc. – Warsaw, IN Nov 2011 – Feb 2013

Quality Assurance Engineer II Contractor

Coordinated, Managed, and Executed Quality/Manufacturing, Training and the motivation of team and client. Quality/Manufacturing support functions included: Planning, Documentation (GMP, QPs, IQs, IQSRs, OQs, PQs, VSRs, ZTMs, ZTRs, and CAPAs), Engineering, Manufacturing, Quality and Maintenance for Zimmer Inc. Executed risk management such as Design and Process FMEA. Assisted with design files and provided management reviews.

Mentored, reviewed documents, revised worked instruction and trainings to produce substantive, effective CAPAs on a reasonable timeline.

Provided multi-team leadership in developing and maintaining the Quality System to meet total customer and regulatory agency needs.

Identified variety of options and quickly choose the most appropriate process method.

Negotiated target completion dates with appropriate personnel from other departments (management review).

Developed risk analysis, project plans, and schedules for projects work activate.

Effective work within a team and cross functionally to expedite completion of critical project tasks.

Provided validation expertise for special process such as cleaning through planning, protocol development, execution support, and report development.

BOUYGUES CIVIL WORKS FLORIDA (BCWF), Miami, FL Mar 2010-Nov 2011

Surface Works Engineer (Sept 2011-Nov 2011)

Utility Project Engineer I (Oct 2010-Sept2011)

Utility Administrative Engineer I (Mar 2010-Oct 2010)

Served as project engineer for surface work monitoring fabrication work, as well as a utility project and administrative engineer, coordinator, and liaison for company designing/building the $1B Port of Miami Tunnel. Conducted daily field inspections. Managed/recorded utility collaboration meetings between BCWF and applicable utility agency owners to discuss facilities in conflict with the Port of Miami Tunnel Project.

Created, managed, and executed surface work and utility material shop drawings of tunnel segments, bridge structures, drainage structures, sanitary sewer material, water main material, electrical lighting and wiring material for Steel Works Fabrication, LLC, Florida Department of Transportation (FDOT) and Miami Dade Water and Sanitary Department (WASD).

Direct preparation of applications; met with permitting agencies, explained work and contract plans, and obtained multiple permits for water main and sanitary sewer upgrade/relocation projects for Watson and Dodge Island. Such as Water and Sewer Department (WASD), Port of Miami, Miami Dade County (MDC) Health Department, City and County Fire Departments, and Department of Environmental Management (DERM).

Prepared informal and formal documents such as requests for information (RFI), change field requests, etc.

FLORIDA POWER & LIGHT, Miami, FL Jun 2006-Dec 2008

Customer Project Manager (Aug 2006-Dec 2008)

Associate Project Designer (Jun 2006-Aug 2006)

Oversaw management responsibilities pertaining to customer projects. Ensured power supply availability to public, private, commercial, residential, and government projects. Collaborated with customers to determine design cost and project schedules.

Utilized proprietary software to establish schedules; developed/monitored budgets, contracts, and purchase orders.

Prepared materials comparisons and analysis reports to identified long lead and potential cost escalating items.

Conducted site inspections to ensure projects complied with corporate policies and federal, state, and local laws.

Liaised with crew, owner, and designees to update project status, address concerns, and resolve existing and future conflicts.

EDUCATION

Master of Science in Engineering Management (Logistics), Florida International University, Miami, FL EGD 2017

Bachelor of Science in Civil Engineering, Florida International University, Miami, FL 2010

Associate of Arts in Architectural Engineering, Miami Dade College, Miami, FL 2006

SKILLS

Computer: Word, Excel, PowerPoint, MS Project Plan, JDE, TrackWise, Agile, Minitab (basic), Visio Design, AutoCAD (basic).

Language: Fluent in English and Spanish.

CERTIFICATION

Associate Project Manager Florida Power and Light

Project Management with Microsoft Project 2010 (In progress) University of South Florida

TRAINING

Measurement System Analysis Zimmer Inc.

ETQ CAPA Training DePuy Synthes

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