Manager Quality

MICHELLE HAIDER, CMQ/OE

**** ** ***** ******, ****** City, MO 64157 • mobile 763-***-**** • ****************@*****.***

CERTIFICATIONS

• Certified Manager of Quality/Organizational Excellence – ASQ March 2006

PROFESSIONAL EXPERIENCE

QUALITY SYSTEM, SR. SUPERVISOR 07/2007 - PRESENT

Catalent Kansas City, MO

Aptuit Kansas City, MO

• Lead Corrective and Preventative Action Quality System activities, including Root Cause Analysis Trending.

o Established a system to communicate and close all past due actions items while keeping new items within their targeted due dates. Eliminated the number of past due Corrective and Preventative Actions from over 600 with a 92% past due rate.

• Manage the deviation, investigation and complaint system.

o Act as an advisor between the Operational Units and their associated Quality Assurance group regarding system and compliance related issues.

o Hold monthly trending meetings with Operations Management to communicate the Root Cause Analysis trending from Deviations, Non-Conformance Reports and Customer Complaints.

• Subject Matter Expert for Non-Conformance Reporting (deviations, complaints, manufacturing investigations) and Corrective and Preventive Action system

• Implemented site wide metrics including Key Performance Indicators and monthly, weekly, and daily site scorecards.

• Lead specialized team while working with a specialized consultant team for the company’s internal Quality Restart project.

• Worked as the manager of internal quality system audits. Implemented a robust audit team and system to ensure company adherence to all U.S. and European Pharmaceutical regulations.

• Manage Change Control and Document Control processes.

QUALITY SYSTEM MANAGER / DOCUMENTATION SPECIALIST 06/2003– 07/2007

Incisive Surgical, Inc. Plymouth, MN

• Lead the Quality System activities, including Document Change Orders, facilitation of calibration / preventive maintenance activities, coordination of employee training, and control of all documentation and quality records.

• Formulated policy, introduction and training of changes to process documents.

• Monitor the review of released engineering change data and change activities to ensure adherence to configuration management procedures and policies.

• Act as an advisor to the engineering team regarding projects, tasks, and operations. Maintain control and compliance of company documentation at an off-site supplier.

• Member of the internal quality system audit team.

o Played a key role in achieving CE Mark within 18 months by helping develop and maintain an auditable ISO 9000 and QSR Quality System.

• Responsible for final review of Device History Records (DHR) in regard to legibility, completeness and traceability

• Member of the Corrective and Preventive Action system review; assisting in the assurance of timely closure of open issues.

SR. DOCUMENTATION SPECIALIST 01/2002 – 06/2003

DOCUMENTATION SPECIALIST 03/1999 – 01/2002

Cordis Endovascular (formerly Teramed, Inc.) Maple Grove, MN

• Lead the implementation and maintenance of the configuration assurance program for the control of all documentation and quality records.

• Performed all aspects of critical and complex engineering changes, including Document Control Order processing, bill of material changes, and manufacturing processes, for all product lines during concept and product development phases all the way through to European commercialization and Phase I and Phase II U.S. Clinical Trials.

• Reviewed over 20,000 batch records and lot history records, including traceability verification of all devices.

o Became the leader in Final Lot Release, including full traceability of all subassemblies to the final assembly.

• Member of the Audit Team including internal audits and all ISO 9000 registration and FDA audits.

DOCUMENT CONTROL COORDINATOR 03/1997 – 03/1999

Biotest Laboratories, Inc. Coon Rapids, MN

• Maintained the documentation department through the processing of Document Change Orders.

• Played a role in each of these areas by helping organize lab reports and assisting in the final validation reports sent to customers.

• Maintained the training program

• Maintained the calibration program and all equipment qualification efforts.

• Member of the Internal Audit Team and was involved in numerous customer, ISO 9001 registration and FDA audits.

EDUCATION

METROPOLITAN COMMUNITY COLLEGE 06/2011 – PRESENT

Enrolled in Bachelor’s Degree of Arts - Business Leadership Studies Kansas City, MO

Will transfer to Rockhurst University in Jan 2013, est. completion 2015

Current GPA: 4.0

MEDICAL ADMINISTRATION GRADUATED 1997

Minnesota School of Business BrooklynPark, MN

Honor Roll

Graduated 3.89 GPA

PROFESSIONAL DEVELOPMENT

• Internal Quality Auditing – North Hennepin Technical College (2-day) – 1998

• Advance Microsoft Word – Globe college – April 1999

• Quality System Auditor Training by Mark Roberts consultant – March 2002

• ASQ Certified Manager of Quality/Organizational Excellence – January–March 2006

PROFESSIONAL SKILLS

• Extensive knowledge and application of ISO 9000,

• Extensive knowledge and application of ISO 13485 for Medical Devices

• Extensive knowledge and application of FDA Quality System Regulations

• Utilizing Lean Programs / Six Sigma

• Self-motivated learner and team leader

• Very organized within an extremely complex environment

• Take initiative to take on work that needs to be done without the need for formal direction

• Maintain a strong customer service attitude with quality system users

MEMBERSHIPS

• American Society for Quality

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