Marie C. Leggette

**** ****** *****, *********, ** 92507

PH: 951-224-4159E-mail: ac0423@r.postjobfree.com

Personal Summary

Extensive experience in Medical Device manufacturing (over 27 years) Worked with Pharmaceutical manufacturing industry (5+ years)

Opened and reviewed complaints, performed investigative actions for submittal.

Effectively work with cross-functional teams.

Perform complaint investigations and reviews.

Run root cause analysis, identification and implementation of CAPAs.

Experienced with FDA auditors.

Perform the reading and understanding of electrical and mechanical schematics.

Major Strengths Include:

Strong organizational skills and excellent team building skills.

The ability to develop creative solutions under pressure.

Quality Systems Management SME

Root Cause Analysis & Investigation

CAPA & Remediation SME

Regulatory Compliance Auditing

(Document/Change Control and Configuration Management Systems),

Manufacturing Pro and Trackwise

Quality Procedures & Technical Writing

Document Change, Label and Complaint Management.

(Customer Complaint handling Systems)

Complaint Maintenance and Review

EMPLOYMENT HISTORY

Quality Engineer Nov.2008 - Mar. 2010

Watson Laboratories, Corona, CA (Pharmaceutical Manufacturer)

Investigate incidents and problems to determine cause; institute corrective and preventive actions planning while closing deviations.

Interface with facilities and equipment maintenance to resolve issues that occur during production

Oversee the Manufacturing Quality Assurance functions directly for the day to day work directions.

Worked directly with the Manufacturing supervisors and operators to assure compliance with all documentation and batch record requirements (ph.) 951-***-****

MQA Supervisor

Watson Laboratories, Corona, CA(Pharmaceutical Manufacturer)

Mar.2005 Nov2008

Responsible for the ensuring the inspectors duties who monitor the documentation, packaging and manufacturing of tablets.

Maintain vigilance of the adherence to SOP’s (Standard Operating Procedures). Assure compliance of inspectors to company documents through training of SOP’s.

Pursue and make corrections in all areas of documentation for MQA.

Supervise all areas of In-Process inspections during rotating week-ends.

Assure that documentations meet Federal Guidelines

Marie C. Leggette

Quality Engineer

June1998- May 2003

Viasys Healthcare, Palm Springs, CA (Medical Device Manufacturer)

Assisted the plan for consolidation of relevant documents to be included in packets for FDA submission of new products.

Liaised with other departments within the company to assure all were compliant with FDA and ISO 9000 requirements as required.

Chairperson of Material Review (MRB) for factory and vendor discrepancies and for the return of non-conforming components to vendors. Lead Auditor for Vendor approvals.

Lead in the planning, which reduced over $400,000 in non-conforming material.

Assisted in the supervision of inspectors; receiving, in-process and final test.

Quality Engineer

June1996- June 1998

Bear Medical/Allied Healthcare, Riverside, CA (Medical Device Manufacturer)

Achieved the set-up of a database for Reliability documentation, supporting the compliant system for FDA reports.

Working relationship with all departments within the facility, assuring that our product reaches the marketplace with excellence.

Certified as Trainer for QSR-GMP Regulations within the company.

Part of team that achieved our company as one of the first ISO-9001 approved in the USA.

Quality Supervisor Jan1980-June 1996

Bear Medical/Allied Healthcare, Riverside, CA (Medical Device Manufacturer)

Supervisor of the Incoming, In-Process and Final Test Inspection functions and in 1994 was promoted to Sr. Supervisor over all inspection functions which included over 25 employees.

Instrumental in achieving turn-around time in Receiving Inspection by 30%.

Developed test procedures and performed quality audits on supplier’s facilities.

Designed and implemented a Nonconformance Report form which eliminated the use of multiple forms saving the company over $75,000 per year in time, labor and storage fees.

EDUCATION

Whittier College Whittier, CA

Bachelor of Science 1974

Compton Community College Compton, CA

Associate of Science 1972

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