• Research and develment Senior Tech with 20+ yrs background with Medical device companies. Quality-focused, with broad knowledge and experience in administrating experimental studies and class B protocols in a research laboratory. • Expertise includes electro-mechanical troubleshooting and repairs, soldering circuit boards, replacing components, and providing technical support to field technicians, nurses and doctors. • Strong quality control background; experienced in metrology in the calibration of manufacturing equipment, gauges and test instruments. • Collaborated with new product development engineers and manufacturing process experts in managing laboratory protocols. TECHNICAL SKILLS • ISO 13485 QMS Certification • Good Manufacturing Practices • Corrective and Preventative Action • ISO 9001 Continuous Improvement and Device Regulations • Calibrations • Good Documentation Practices • Good Lab Practices • Minitab • Microsoft Suite 2010, Excel, Word, Outlook, Access, Power Point, One note • CFR 21 p11Testing and Validation Compliance • SME of the Hunterlab Colorquest XE Spectrophotometer • Adobe Acrobat Pro 9 • MicroVu software • Blue Hill Instron software for tensile testing • Wasp Barcode Technology

Highlights:

• Medical Device Senior Technician
• Laboratory equipment IQ, OQ, PQ and test method validation
• FDA and CAPA management
• Testing, writing protocols, gauge R
• Microsoft Excel, word, outlook, access, and power point
• Certified in Blue Hill,
• Product development, GLP, GMP, PPE
• Engineering Change Request