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Hollister, CA, 95023
... Corlund Electronics, Tustin, California July 2002-August 2003 Director of Engineering & Quality Developed test fixture to eliminate hardware failure for medical instrument and to meet FDA approval. Created and implemented cross training schedule for ...
- 2017 Jan 03
San Jose, CA
... Primary market is IVD biotech instrumentation (ISO 13485/FDA). Secondary markets include management consulting, underwater drones, wearables, and capital equipment. Select Clients and Budgets – MBARI, HTG ($2.4m), Tecan, Biorad, Thermo-Fisher, ...
- 2016 Jun 24
Gilroy, CA, 95020
... • Providing leadership to a leading medical device company under a Warning Letter from FDA to establish adequate design and process validation methodologies which also significantly improved production efficiencies. • Preparing a regenerative ...
- 2016 May 08
San Jose, CA
... Unified Software Development Process, through all phases of software development, for Class 3 medical devices submitted to the FDA • Scheduled all formal peer-to-peer software feature reviews, organizing all review materials and project plans for ...
- 2014 Sep 25
San Jose, CA, 95138
... SUMMARY of Qualifications: • A combined experience in Quality Control, Quality Assurance, Manufacturing Operations and Quality Compliance in a GMP and FDA regulated industry. ...
- 2012 Sep 18
San Jose, CA, 95118
... Development of Clinical Sop’s (Standard Operating Procedures), Clinical Statistics for Non-Statisticians, Good Clinical Practice (GCP), Drug Safety and Adverse Events Reporting, Medical writing, Clinical Monitoring, FDA auditing and inspections. ...
- 2012 Jul 30
Santa Cruz, CA, 95062
... • Employed defined practices and policies such as ISO (International Organization for Standardization), CGMP (Current Good Manufacturing Practices) Standards, FDA/QSR [21CFR820] for Class II Analysis Instrumentation in order to select methods and ...
- 2012 Jul 19
San Jose, CA, 95111
... -Familiar with GMP, FDA, and DEA regulation. Prepared for FDA and DEA audits by assisting QA’s internal audits. Orquest Inc.-- QC Associate (temporary position) (March’02-July’02) -Worked within GMP, FDA environment. -Executed validation protocols ...
- 2012 Jun 12
San Jose, CA, 95136
... • Expert at collecting, recording and analyzing quality attribute data for ISO 9001, 13485(medical), FDA quality management compliance. WORK EXPERIENCE 2/2005 – 10/2011 Kimball Electronics, Fremont, CA QA Inspector • Performed incoming inspection of ...
- 2012 Apr 06
San Jose, CA, 95123
... Assisted QA and Compliance department with QA audits of clinical database, client and FDA audits of the company. Central Files Associate (2000-2004) . Processed visit reports submitted to Central Files for multiple Pharmaceutical clinical trials. . ...
- 2011 Jul 24