Laura Darveaux
Columbus,NE
Summary
Experienced Quality Technician with a demonstrated history of working in the medical device industry 25 years. Skilled in Failure Mode and Effects Analysis (FMEA), Validations, Employee Training, Teamwork, Quality Control, Technical Writing & Document Changes, and Skilled Multi-tasker. Strong engineering professional.
Overview
9
9
years of professional experience
Work History
Quality Engeneering Tech
BD Pharmaceutical
Columbus , NE
02.2020 - Current
- Performed validation tests on new products to ensure accuracy and quality standards were met.
- Provided technical support and guidance during production runs to ensure compliance with validated protocols.
- Assisted with procedures, protocols, training, and acceptance criteria for all validation activities.
- Performed troubleshooting activities when needed in order to resolve problems quickly and accurately.
- Coordinated with other departments such as Quality Assurance, Manufacturing, Engineering and Production involving EWO's, validation, QN closures, document changes, & engineering studies.
- Inspected products for defects and conformance to customer specifications using precision measuring instruments.
- Monitored production processes to ensure quality standards were met and documented results of inspections.
- Analyzed data from process control systems to identify trends in product quality.
- Identified areas for improvement in existing processes, procedures, and equipment.
- Provided technical support to other departments regarding quality related topics and initiatives.
- Trained new employees on proper use of test equipment and inspection techniques.
- Worked closely with Doc Control on document changes including writing, routing, object linking and training .
- Reviewed customer complaints and identified potential sources of quality issues.
- Participated in internal audits to ensure compliance with applicable regulations.
- Generated reports summarizing inspection results, defect trends, and other statistical data.
- Adhered strictly to Good Manufacturing Practices guidelines at all times.
- Examined products and materials for defects or deviations to remove or discard non-conforming items.
- Documented inspection results by completing reports and logs and summarizing and entering data into quality database.
- Consulted with engineers to resolve quality, production and efficiency problems.
Injection Mold Technician
BD Pharmaceutical
Columbus, NE
04.2015 - 04.2020
- Performed visual inspections of molds to detect any signs of damage or wear.
- Conducted routine maintenance and repairs on molds, such as cleaning and lubricating parts, and pulling / setting molds.
- Monitored molding process parameters to ensure optimal performance of the machines.
- Efficiently operated 15 KM hydraulic presses and 8 Electric Toyos.
- Transferred to NAMc and operated multiple Hybrid Arburg Presses.
- Conducted first piece and final shot collections to include visual inspections .
- Aided in OQ , PQ molding validations and inspections . Worked closely with Engineering and Quality departments in executing successful validations.
Education
Some College (No Degree) - Pharmacy Technician
Ashworth College
Norcross, GASome College (No Degree) - Horticulture
Central Community College
Grand Island, NESome College (No Degree) - Generals & Information Technology
Central Community College
Grand Island, NESkills
- Multitasking and Time Management
- Organizational and communication skills
- Good at problem solving
- Product Inspection
- Measurement tools - pin gauging, calipers, bench testers, comparator, Keyence
- Documentation skills Including Change Forms, Validation Protocols, Work Instructions
- Inspections and reviews
- Workplace Safety
- Training abilities
- Visual Inspections including MSAs
- Investigations - customer complaints
- SAP proficiency
- Quality Notifications
- Quality Management Systems
- Data entry
- Microsoft Excel, One Note, Word, Powerpoint
- Assist / Perform Validations including process parameter settings, inspections, training
- CAPA investigations
Timeline
Quality Engeneering Tech
BD Pharmaceutical
02.2020 - Current
Injection Mold Technician
BD Pharmaceutical
04.2015 - 04.2020
Some College (No Degree) - Pharmacy Technician
Ashworth College
Some College (No Degree) - Horticulture
Central Community College
Some College (No Degree) - Generals & Information Technology
Central Community College