Program/Project Analyst (Contractor) Resume Example Company Name

PROGRAM/PROJECT ANALYST (CONTRACTOR)

Professional Summary

A dynamic, adaptive and detail oriented professional with 5 plus years of experience in the field on Quality Engineering Systems and Operations, Project Management and Continuous improvement.
Accomplished Professional with strong problem-solving skills, Initiative team player with excellent analytical and organizational skills, proven ability to manage multiple projects ensuring timely completion of projects without compromising quality.
Comprehensive knowledge of ISO 13485, ISO 9001, FDA Good Documentation Practice (GDP) and FDA Guidance documents.

Skills

Professional Experience

Company NameCity, StateProgram/Project Analyst (Contractor)07/2019 to Current

Oversee and direct the operational aspects and serve as liaison between project management and planning, Quality management and supply chain for launching New Product Introduction projects.
Work to continuously improve the process, own the deliverables and reduce time using A3 methodology.
Create, update and release product change notification including Bill of Materials, Specifications updates, etc. via Agile PLM/MAP.
Collaborate with core team engineers and manufacturing line to develop and report project plans, schedules, support regulatory submissions and documentation throughout product release.
Develop and maintain tracking/reporting mechanism to provide current project resource data such as demand vs. supply, supplier management activities and resource allocation.
Support program manager to reflect the latest project progress and status using Microsoft project and spreadsheets; identify any late tasks, escalate risks and issues as necessary to senior leadership.
Communicating with cross-functional teams on upcoming documentation deliverable deadlines and maintain Project Plans and timelines.
Work with supplier quality engineer to complete the PPAP for new part submission or for approval of any change to an existing part or process.
Contribute to the continuous performance and quality improvement effort through a supportive monitoring and change management process for all projects.

Achievements:

Successfully launched new products with different platform in US, EU, and Global Countries.
Fixed supplier issue of non-conformance of over 2500 inventory parts.
Received training on Lean Sigma DMAIC Problem Solving.
Created and maintained 10 plus Bill of Materials of various products in Agile MAP and SAP.

Company NameCity, StateDesign Quality Engineer (Contractor)01/2019 to 06/2019

Work with Standards Compliance Engineers to conduct gap assessments for Trauma/CMF products aiming to achieve European Union (EU) Medical Device Regulations (MDR) compliance.
Assisted Quality Assurance Manager in coordinating the development and implementation of activities related to J&J Quality Management System.
Assist Product Development team in the creation of GSPRC (General Safety and Performance Requirements Checklist) and functional/design requirements.
Support the Regulatory Department in reviewing Technical Files(TF)/Technical Documentation (TD)/Design Dossiers and 510(k) submissions.

Company NameCity, StateProduct Development Quality Engineer (Contractor)01/2016 to 12/2018

Authored and executed Verification & Validation (V&V) matrix with the company's Design Control requirements and consistent with FDA, ISO 13485, and MDD requirements.
Assisted with the development and implementation of corrective and preventive action plans to improve overall ISO compliance and quality results..
Prevented recurring failures and reduced risks by performing root cause analysis, feasibility, and characterization studies to identify and address existing issues.
Created and supervised Risk Management Activities partnered with Principal Quality Engineer including dFMEA, hazard analysis to assess potential design risks or failures.
Developed test methods, establish acceptance criteria, and assess risks to calculate sample size and performed data analysis results to draw conclusions and formulate recommendations.
Created and governed work instructions, reports and forms with test engineers to ensure standardization of practices in compliance with Cook's quality systems.

Achievements:

Contributed to successful FDA 510(k) approvals for various Angiographic Catheters.(K171264, K172635, K181144, K180054 and K161801)
Played an integral member of R&D team by leveraging engineering knowledge in conducting complaint evaluations, CAPA investigations and test failure investigations on the recall devices.
Special Project : Assessed Validation team in executing test method validation. Trained operators to verify the inner diameter of the catheter on the bond tip site.

Education

Master of Science:Engineering Management2015California State University Northridge, City

Bachelor of Science:Electronics Engineering2012Solapur University, City

Certification

Quality Management, California State University Northridge, May 2015.

Resume Overview

School Attended

Job Titles Held:

Degrees

Master of Science : Engineering Management 2015
Bachelor of Science : Electronics Engineering 2012