PROFILE
• ASQ Certified Quality Engineer with over six years of QA and R&D experience in medical device manufacturing and health incentives software
• Experienced in product development, CAPA, auditing, change control, personnel management, training, and working with cross-functional teams to achieve business objectives
• Seeking position to lead quality improvement initiatives for a medical device manufacturer
SOFTWARE SKILLS TRAINING CERTIFICATIONS
JIRA, TrackWise, Manager Plus, AAMI QSR CQE (ASQ), CQIA (ASQ)
Microsoft Office
WORK EXPERIENCE
ChipRewards, Inc. Birmingham, AL
Team Lead, Quality and Release Management (April 2013-Present)
• Team Lead for health incentives IT firm specializing in health behavior modification.
• Quality team lead and ScrumMaster for agile development team.
• Lead various Product Management efforts around product testing and quality, vendor evaluation, and improving operations quality, efficiency, and effectiveness.
• Interned as part of MPH degree from August 2012–December 2012 in addition to working full-time at BioHorizons Implant Systems and maintaining 4.0 GPA.
BioHorizons Implant Systems Birmingham, AL
Quality Engineer (October 2010-April 2013)
• Quality Engineer for Class II dental implants manufacturer and biologics distributor, with sales in 80+ international markets.
• CAPA Coordinator: Hosted CAPA Review Board, administered process through Investigation and Root Cause Analysis, Action Plan generation and implementation, and Effectiveness Check. Maintained comprehensive record set, and generated executive summaries.
• Calibration Coordinator: managed calibration of nearly 600 items using Manager Plus, including calipers, micrometers, gages, and thermometers. Worked directly with vendors and conducted new calibration supplier evaluation.
• Lead Internal Auditor: audited Quality Management System as part of CEO-approved annual schedule. Was an active participant in FDA (1x) and ISO 13485 (2x) audits, including direct contact with auditors. Performed external audits (2x) of packaging and calibration suppliers.
• Change Control Board member: reviewed Document Change Requests (DCRs) on bi-weekly basis, initiated over 50 original DCRs approved by the board, including procedure enhancements and overhaul of training documentation.
• Design Review Committee member: served as a Quality reviewer for entirety of a major design project.
Hygia Health Services Birmingham, AL
Research and Development Engineer (February 2009-October 2010)
• R&D Engineer for C...
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