Juliette Kistler
Quality System Specialist @ Prospect Life Sciences
About
Experienced Document Control/Quality Systems Specialist in the Medical Device industry. Skilled in Document Control, Training, Corrective and Preventive Action (CAPA), and Continuous Improvement in accordance with ISO 13485 and FDA 21CFR820.
United States
Golden
Consumer Goods
Gap Analysis, Design History, Documentation Control, Analytical Skills, Internal Audits, Quality System Compliance, Handle Confidential Information, Data Retention, Confidentiality, Written Communication, Microsoft Word, Attention to Detail, Standard Operating Procedure (SOP), Performance Metrics, Records Management, Employee Training, Microsoft Office, Administration, Training and Development (HR), Collaborative Problem Solving
Experience

Direct Support Professional
Self-employed
Golden, CO
• Submit documentation to maintain compliance with state and federal regulations • Provide support to host home clients; e.g., preparing nutritious meals, administering medication as required and transporting to doctor’s appointments and day program

QA Coordinator
SteriTec Products Inc.
Product complaint investigations and reporting Non-conforming item investigations and reporting Corrective and preventative actions (CAPA's) efficacy verification Internal and external audits

Customer Service Administrator/Mail Preparation Total Quality Management Coordinator
Pitney Bowes Presort Services
Provides Customer Service for Business Mail Presort customers. Assists Sales department with creation and maintenance of documentation Addresses non-conforming mail issues with customers Monitors internal production and quality processes Implements corrective and preventive action Conducts internal audits based on USPS Mail Preparation TQM requirements (ISO 9001:2000) Trains employees on Production, Quality and Transportation Best Practices

Quality Control/Document Control
Responsible for the creation, revision and release of all documentation Maintenance of training program, corrective action plan, process deviations Responsible for compiling and reporting Production Daily Yield Reports Managed customer complaints

Quality System Inspector, Lead
Sorin Group USA, Inc
Led a team of inspectors/auditors Investigated and implemented corrective action for customer complaints Responsible for the creation and development of procedures

Production Technician
Vitrolife, Inc
2002 - 2003 Investigated and purchased production equipment based on process requirements Developed procedures for the operation/calibration of instruments and equipment
Juliette Kistler's Contact Information
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