Gail Wiegand's Email Addresses & Phone Numbers

📖 Summary

Quality Management System Project Manager @ Getinge Responsible for managing, monitoring, and reporting of actions planned and taken to address audit inspection observations or other changes to the Quality Management System. Evaluation of project resource needs and availability; identifying and reporting gaps and constraints. Assistance to teams in the development of action plans and implementation schedule, and the verification of completed actions. Assurance that documentation is in compliance with QMS procedures and industry standards and regulations. Merrimack New HampshireStaff Quality Systems Specialist @ Elbit Systems of America I am excited to be taking on a specialized role within KMC Systems at Elbit Systems of America. I will be focusing on compliance to quality standards and regulations, and maintaining that compliance as our company continues to grow and implement lean practices. From January 2017 to May 2018 (1 year 5 months) Merrimack, New HampshireDirector of Quality Assurance and Regulatory Compliance @ Elbit Systems of America I managed a team of 20+ employees in the Quality Assurance and Regulatory Compliance department for the medical device business unit of Elbit Systems of America. We are a $68M contract developer and manufacturer of laboratory equipment as well as FDA regulated medical devices. I held responsibility for all aspects of the Quality Management System, maintained our ISO 13485 certification, acted as interface with the FDA on behalf of our customers, and supported all of our various product lines through Quality Engineering, Regulatory Compliance, Receiving Inspection, Supplier Quality Management, and Software Quality Assurance. KMC Systems functions as a Lean Manufacturing environment, customizing our approach to meet the needs of our customers, while maintaining industry quality standards and regulatory compliance. From January 2004 to January 2017 (13 years 1 month) Merrimack, NHQuality Manager/Management Representative @ Elbit Systems of America Served as Co-Manager of the QA Department for an interim period, eventually assuming responsibilities as Director. Managed transition activities from ISO 9001 to ISO 13485. From June 2003 to January 2004 (8 months) Merrimack, NHQuality Engineer III @ Elbit Systems of America Successfully transitioned two manufacturing programs from Bayer Diagnostics to KMC Systems over the course of 7 months.Held primary QA Engineering role for up to 4 contract manufacturing programs at one time.Accepted/rejected product, maintained Device History Records, created/maintained/controlled procedures and quality records.Performed failure analysis and provided troubleshooting to address supplier quality issues, complaints, CAPAs, and non-conforming material.Supported development programs through risk analysis and design reviews.Supported Quality System through the update of procedures and personnel training.Supported FDA inspections. From March 2000 to June 2003 (3 years 4 months) Merrimack, NHManufacturing Systems Engineer @ Bayer Diagnostics (formerly Chiron Diagnostics) Developed Manufacturing calibration and test procedures for bDNA instrumentation.Responsible for all related Work Instructions, Engineering Change Notices, Deviations, SOPs, and Calibration Procedures for multiple product lines.Evaluated acceptance testing on all medical device products daily. Performed root cause analysis, and implemented corrective actions.Supervised daily activities and trained employees.Supported FDA inspections. From April 1997 to April 2000 (3 years 1 month) Oberlin, OHSenior Quality Control Chemist, Systems Engineering @ Chiron Diagnostics (Formerly Ciba Corning Diagnostics) Assisted in the systems-level evaluation and development of the Q2000/Quantiplex bDNA System 340.Performed data analysis, validation, and generated reports to the Design History File. Evaluated statistical data on assay performance and subsystem testing performance. From April 1996 to April 1997 (1 year 1 month) Oberlin, OHSenior QC Chemist-Reagents @ Ciba Corning Diagnostics Worked with, trained, and oversaw the Manufacturing/QC personnel responsible for 34 clinical chemistry products to be filled into multiple configurations--liquid and powder reagents. Planned and executed large projects for calibrator and control assignment.All duties as listed under Associate Scientist. From May 1993 to April 1996 (3 years) Oberlin, OHAssociate Scientist- Reagents @ Ciba Corning Diagnostics Coordinated and prioritized multiple projects across the team, along with daily manufacturing requirements.Tested and applied troubleshooting skills to reagents and instrumentation in an FDA regulated environment.Approved or rejected intermediate blends and final release of products. Worked with Production to resolve nonconforming product issues.Maintained all instruments used for testing, environmental records, FDA required documentation. From June 1992 to May 1993 (1 year) Oberlin, OHMedical Technologist (ASCP), Clinical Chemistry @ St. Joseph Hospital Performed all testing in the clinical chemistry department using both manual methods and automated devices.Communicated patient results across departments.Used troubleshooting skills to resolve issues with equipment or test results.Maintained equipment records and environmental records; interfaced with auditors as necessary.Worked across departments, communicating with physicians and nursing staff on setting priorities, changes to test requests, and any delays in patient results.Performed phlebotomy as needed across the hospital, including emergency room, outpatient lab, labor and delivery, and all patient floors. From June 1988 to June 1992 (4 years 1 month) Lorain, OH