Quality / Inventory Analyst Resume

SUMMARY

Certified Quality Lead Auditor (ISO 9001 QMS) with 5 years of combined experience in the Healthcare Administration, Information Technology Services, 3rd party Registration Auditing, and Manufacturing. Most recently responsible for overall Quality Management System (QMS) governance in the Healthcare field while also participating in Project Management, Systems / Requirements Analysis in ERP designs, Business Development of Government Contracts, and Supplier Evaluations.
Skilled and Certified in auditing quality management system processes, products, and services (ISO19011:2011)
Thrives in a team environment with strong organizational and communication skills
Well versed in the ISO certification and maintenance process (CAPA, Continuous Improvement, Document Control, Defect Trending); both as auditee and 2nd / 3rd party auditor
Excellent proficiency with MS Office Suite 2007 - 2013 and other database computer applications
SharePoint 2010 / 2013 implementation expertise utilizing LEAN and AGILE methodologies
Skilled with presenting complex information in a simplistic, business orientated manner
Clear understanding of the Design and Development Life-Cycle, Functional Requirements Analysis, and Testing of various company functions (Procurement, Operations, and Human Resource ERPs)
Enthusiastic problem solving skills in the technical and conceptual environments
Proficient understanding of ANSI 14.5, Geometric Dimensioning & Tolerancing

PROFESSIONAL EXPERIENCE

Quality / Inventory Analyst

Confidential

Responsibilities:

Developed measurable policies, objectives and the procedural guidelines to verify and validate the customers’ requirements are being met
Developed, planned, performed, and maintained the Internal / External Audit program in accordance to ISO 19001:2011
Perform ad hoc inventory / data reporting and analysis for all program / project management
Developed and conducted companywide training for continuous improvements, corrective actions, and various other Quality Management System related topics
Performed annual executive meetings to report data trends, corrective actions, continuous improvements, preventative actions, and various other audit derived findings

Quality Assurance Analyst

Confidential, Landover, MD

Responsibilities:

Manage and championed the Organization’s Quality Management System through four ISO 9001:2008 QMS surveillance audits and one re-registration audit, with a 100% success rate and zero (0) major non-conformances
Design and developed SharePoint 2013 to standardized company policies, objectives, and procedural transparency to establish measurable performance indicators
Participated in product design reviews to provide input on functional requirements, product designs, schedules, and potential risks for commercial and government applications
Responsible for ensuring the technical direction of developers remain in scope of business requirements and schedules
Lead Quality Assurance Consultant for a 500+ employee government Healthcare Contractor
Assisted Procurement Director in Business Development activities, proposal drafting, and programs establishment

Management Consultant and QA / Internal Auditor

Confidential

Responsibilities:

Perform process mapping, management assessments, and staff trainings to businesses of various industries (aerospace / medical device / PCB) to ensure compliance with ISO 9001 / 13485 / AS9100 Rev. C through a process focused approach
Project Team Member responsible for design, development, and implementation of Quality Management Systems with a 100% certification success rate
Conduct 3st party preliminary audits as a consultant to ensure all aspects of the QMS were in compliance with relevant standard(s) to ensure successful completion of stage 2 registration audits

Business Development Analyst / QA Internal Auditor

Confidential

Responsibilities:

Participating team member on (4) four Certification audits (9001:2008, 13485:2003, AS9100 Rev. C) in the following industries: Medical Device, Electrical Engineering/Design Services, and Human Capital Management
Performed internal (1st party) audits and provided QA support in documentation control, preventive/corrective actions, and continuous improvements
Internal/external auditor and service deliverables representative responsible for ensuring accurate certification records, schedules, and budgets