Experience

September 2007 - Present  Quality Engineer
Covidien Surgical Devices, North Haven, CT

Utilized Six Sigma Methodology and Project Management training to lead cost reduction and cycle time improvement projects, resulting in over $750k in total savings through improved process capability evaluation, developing new sample plans and more timely and accurate defect investigation. Managed or contributed to over 50 validation/quality improvement projects to increase manufacturing efficiency and flexibility. In charge of the collection, analyses and interpretation of statistical process control data, performing defect analysis, initiating and verifying corrective actions. Initiated standard templates and practices that improve workflow and reduce time spent on repeated tasks. Received recognition for project performance, exceeding expectations, work across business units, commitment to quality and innovation. Completed corporate DMAIC Six Sigma Green Belt Certification.

April 2004 – September 2007  Validation Engineer II
Pharmaceutical Services Corporation, Pasadena, CA

Managed validation and qualification consulting projects at a variety of pharmaceutical, medical device, diagnostic, and cosmetic companies and internal company projects.  Possess strong interpersonal skills to coordinate activities, lead project teams and train personnel.

Generated and/or executed requirements, protocols, procedures and summary reports for:

·         Automated Packaging Lines (Solid and Liquid Dosage Fillers, Cappers, Labelers)

·         Calibration Manager, Spreadsheet (Excel/DaCS) and Oracle Clinical Software

·         Manufacturing Equipment (Autoclaves, Sterilization Ovens, Incubators)

·         Test Methods (Fourier Transform IR, Penicillin Activity)

·         21CFR11 Gap Analysis (Electronic Record Management)

·         Facilities (Sterile Filling Suite, Controlled Manufacturing Areas)

·         Computerized Systems and Networks (GxP File Server and Associated Network)

·         Cleaning Procedures (Penicillin Decontamination, Manual Cleaning of Aseptic Parts)

Developed and Implemented Quality Control System to support validation efforts, procedures include:  Software Development Life Cycle, Good Documentation, Change Control, Validation and Study Procedure, Performing Risk Assessments and the applicable forms.  Trained users on new procedures.

Clients include: