Susan Seidenspinner Email & Phone Number

Sturtevant, Wi

25212 W. Illinois Route 120 Round Lake Il 60073

Research and Development Senior Technician• Led projects and trained employees test methods related to luer-activated devices that resulted in FoC products now available in market.• Developed study protocols, performed physical and functional testing, conducted statistical analysis, wrote SOP’s for use of lab equipment and prepared final reports that alleviated time for engineers.• Provided expert documentation of highly detailed confidential procedures. Authored and led class B protocols and confirmed critical project deadlines were met or exceeded.• Designed creative prototype fixtures that ensured repeatability, enabling smooth test method validations. • Lead technician for numerous extrusion runs of non-PVC tubing by traveling to company facilities in Costa Rica and Puerto Rico collaborating with manufacturing engineers.• Produced $3K in surplus to our lab budget for 3 consecutive years by installing Microsoft Access to monitor equipment calibrations that resulted in increased cal intervals or taking unused equipment out of service.• Performed Gauge R&R studies for test method validation and ensured qualification (IQ, OQ, and PQ) of all lab equipment utilized in class B studies preventing a possible CAPA.• Educated in ISO procedures and test methods using ISO certified gauges. • Lead technician for protocol held in climate controlled chambers that involved continuous documentation of temperature and humidity.• Volunteered to take part in pre-clinical assessments of our products while observing customers through a two way mirror. (C.U.B.)• Led class B protocols for real time and accelerated aging on products.

1525 Howe St, Racine, Wi 53403

• Material and room prep for human subject research.• Prepare chemical formulations and excel data sheets for test subjects.• Application of chemicals used in test procedures.• Verification of product claim certification. • Manage new product development studies.• Accumulate and analyze data produced by testers and computer generated photography.• Record laboratory test results and accumulated data in excel.

3037 Mount Pleasant Street, Racine Wi 53404

Please see description below followed by previous positions held within this company

3037 Mount Pleasant Street, Racine Wi 53404

Medical Repair Technician• Maintain ISO 9001-2000 standards and GMP.• Clean and sterilize instruments and electrical equipment.• Troubleshoot equipment accuracy problems and contact appropriate vendor/ personnel to get problems resolved.• Diagnose and estimate cost of service.• Repair Circuit boards by unsoldering bad components such as LED’s, resistors, potentiometers• Provide customer support.• Maintain all traceability of repair history.• Perform necessary repair. Calibration Technician• Troubleshoot equipment accuracy problems and contact appropriate vendor/ personnel to get problems resolved. • Develop and implement specific calibrations for new equipment.• Perform routine calibrations of equipment used in manufacturing and quality. Incoming and Calibration Quality Control Inspector • Test and inspect incoming raw materials, components, finished products and first articles per ANSI/ASQ standards.• Evaluate vendor material certification for compliance with specifications.• Generate nonconformance and engineering change requests as required. In Process Quality Control Inspector• Test and inspect product in various stages of the manufacturing process per ANSI/ASQ standards. • Assure all traceability requirements are met.• Maintain in process and packaging logs. Product Release Quality Control Inspector• Inspect all products and packaging per ANSI/ASQ standards.• Assure all traceability requirements and quality guidelines have been processed and documented.• Release of final product for the consumer.