We provide IT Staff Augmentation Services!

Coordinator Resume

3.00/5 (Submit Your Rating)
Hire Now

EXPERIENCE:

QA consultant in various medical device, bio - pharma and high tech

PROFESSIONAL EXPERIENCE:

Confidential, Santa Clara

Coordinator

Responsibilities:

  • Coordinates Genomics Production Confidential related tasks
  • Performs gap analysis for QMS compliance
  • Creates reports for management
  • SharePoint admin
  • Coordinates LMS function

Confidential, San Carlos

Consultant

Responsibilities:

  • Facilitated Confidential related projects
  • Documented Confidential activities
  • Performed gap analysis for QMS compliance
  • Created Confidential reports and trend analysis

Confidential, Puerto Rico

QA/Project Manager

Responsibilities:

  • Reviewed and approved computer systems validation
  • Coordinated Confidential, deviation, change control process and SPC automation
  • Created projects and SPC reports using InfinityQS suite of applications
  • Participated in process quality validation and analysis of quality data

Confidential, Redwood City, CA

QA Consultant

Responsibilities:

  • Wrote requirements documents, test protocols, SOPs and process mapping
  • Uses Assembla, Wiki, Plant UML and Word in documentation
  • Coordinated Confidential and customer complaints handling

Confidential, Santa Clara, CA

QA Consultant/PM

Responsibilities:

  • Facilitated creation of automated Confidential and complaint system
  • Identified and documented gaps for Confidential, complaints
  • Wrote investigation and deviation reports

Confidential

QA Consultant

Responsibilities:

  • Wrote test protocols, study reports and other technical documents for Device Dev dept
  • Worked with SME in getting content for product

Confidential, Fremont, CA

QA Consultant/MSDS Author

Responsibilities:

  • Wrote MSDS SOP/templates and updated 500 MSDS
  • Wrote requirements specifications and performed training gap analysis
  • Used Agile for managing documents

Confidential, Burlingame, CA

QA Manager

Responsibilities:

  • Leveraged Confidential investigations to find solutions for purchasing, customer service and the company’s bottom line
  • Conducted product complaints investigations
  • Trained the whole company in Quality Tools such as Statistical Quality Control, and other data analysis, root cause analysis, quality processes, gap identification, workflow simplification and process improvements
  • Wrote Quality Manual, MDR, Confidential and CAR forms, procedures and templates and validation test protocols/reports to establish quality system
  • Responsible for all medical device reporting, Confidential coordination, and quality audits in compliance with QSR and other regulatory standards
  • Assisted management in implementing the QMS to improve current process and reduce customer complaints
  • Maintained records, managed QA Consultants and formatted documents

Confidential, San Mateo, CA

QA Consultant

Responsibilities:

  • Wrote test protocols, specifications, program plans and SOPs
  • Used Livelink and SharePoint as document management system

Confidential, Sunnyvale, CA

QA Manager

Responsibilities:

  • Conducted product complaints investigations
  • Wrote QA manual, SOPs, Forms and validation test protocols
  • Wrote Confidential, risk assessments and product investigation reports
  • Performs QA functions from writing SOPs, measuring quality, Confidential and MDR coordination and training and preparation for CE submission
  • Identified needed regulatory requirements for the software portion of the product in preparation for CE compliance
  • Maintained records, managed QA Consultants and formatted documents

Confidential, San Jose, CA

QA/PM

Responsibilities:

  • Prepared the software product for CE submission by preparing all templates from customer requirements, Software System Specs to test protocols with traceability and risk management element

Confidential

QA Consultant

Responsibilities:

  • Responsible for drafting, editing and maintaining technical documents for the training organization
  • Created and modified flow charts for technical documents using Visio
  • Used Captivate in elearning related training documentation

Confidential, CA

Trainer

Responsibilities:

  • Conducted training using Webex
  • Resolved software-related complaints
  • Documented testing related results
  • Tested the product, wrote documentation and delivered the 1-hr online training using Webex
  • Collaborated with users and sales engineers on product presentations and user surveys

Confidential, San Jose, CA

Technical Writer

Responsibilities:

  • Wrote system validation protocol/reports and coordinated all system validation documentation

Confidential, San Jose, CA

QA Consultant

Responsibilities:

  • Participated in the testing of Confidential Document (eDMS) and Process management system
  • Wrote press releases, technical support documents, training materials, User’s Manual, Reference Manual for Document Change Management system. Handled customer complaints and product deviations. Performed internal QA audits.
  • Supervised 1 Customer Support Specialist and 1 QA Consultant.
  • Tested the software product and performed other software QA functions

Hire Now
Report an issue

We'd love your feedback!

Privacy Policy
Resume Categories
Client Services
Job Seekers
Visa Sponsorship