Quality Assurance Professional Experience

A highly motivated and results oriented Quality Assurance Professional with 9+ years of experience working with FDA Compliance in Medical Device Industry on Post-Market Surveillance. Consistently delivered results following up to completion on task. Key responsibilities included initial intake of complaints, identifying MDRs and non-reportable for timely processing. Performed multiple job functions prioritizing competing task.

PROFESSIONAL EXPERIENCE

Siemens Medical Solutions USA, Inc., Mountain View, CA 2016-2017

HC – Regulatory Technical Specialist II

Processed four years of backlog complaints in various stages of complaint process.

Audited complaints to identify MDRs and non-reportable, HREs & CAPAs.

Reviewed and updated complaints for accuracy for FDA compliance.

Completed reports and performed pre-closing task.

World Financial Group of Transamerica, Pleasanton, CA 2014-Present

Financial Services Associate

Presented and educated prospective clients of Basic Financial Literacy.

Excellent written and oral communication.

Familiar with Anti-Money Laundering, OFAC and FATF.

Invacare, Inc., Elyria, OH 2014-2014

Project Specialist – Contract Validant

Complaint Remediation of legacy complaint files.

Terumo Cardiovascular Systems, Ann Arbor, MI 2011-2013

Project Specialist III – Contract Validant

Market Product Surveillance/QA Complaints

Investigated 20-30 complaints daily documenting associated information in a timely manner.

Used electronic data base to process complaints and created hard copy for storage.

Conducted DHR review, evaluated risk of failures using established Failure Mode Analysis criteria.

Product Returns

Received returned product and associated them with customer complaints on file.

Assigned returned product to cages for Engineering Group for analysis.

Red tagged and documented damages product and components for scrap.

Regulatory – Recalls, Corrections and Removals

Packaged and emailed Advisory Notices to Consignees.

Performed Effectiveness Checks for approximately 250 Consignees.

Collected and verified completeness of Response Forms for filing with the FDA.

CooperVision, Inc. Pleasanton, CA Contract – Aerotek 2010-2011

Regulatory Document Control Administrator – Contract Aerotek

Organized and maintained open and closed regulatory files of PMAs and 510(k)s.

Prepared PMA and 510(k) documents for submission to FDA according to management request.

Maintained Regulatory files and documents for easy access on and off site.

Conceptus, Inc., Mountain View, CA 2008-2010

Product Surveillance

Reviewed and evaluated three years of legacy complaints for processing.

Coordinated with internal and external groups, i.e. Manufacturing, R&D, Regulatory and Quality Technicians for accuracy of documentation.

Investigated and documented non-reportable, MDRs, and Med Watch files and maintained document storage on and off-site.

Boston Scientific Neuromodulation, Valencia, CA 2008-2008

Remediation Quality Surveillance Specialist – Contract

Remediated legacy reportable and non-reportable complaint records for timely processing.

Verified file content for accuracy of documentation and prepared for losing.

Remediation resulted in successful FDA Compliance Audit.

FoxHollow Technologies Division/Ev3, Inc., Redwood City, CA 2006-2008

Compliance Specialist II

Supported Quality Assurance team accurately processing complaints in a timely manner.

Successfully communicated with peers, sales force and product technicians.

Set up and maintained complaint file system to final resolution on and off-site storage.

Stedim, Inc. / Satorius, Inc., Concord, CA 2004-2006

Cleanroom Supervisor

Cleanroom supervisor overseeing the implementation of Quality System Regulations.

Verified accuracy and completion of Device History Records (DHR).

Validated measurements and finishing tools for production process.

EDUCATION

BS Business Administration University of Phoenix San Ramon, CA

CERTIFICATES

Biotechnology Certificate Ohlone Community College Fremont, CA

PROFESSIONAL ASSOCIATIONS

Pleasanton Community Toastmasters

Contact this candidate