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Livermore, CA, 94550
... Projects included: • Working with Regulatory Affairs under the direction of the Manager, Document Control, to submit two NDAs electronically to the FDA in one year. Submitted MAA filing to the EMEA. • Well-versed in hyperlinking, bookmarking, ...
- 2010 Dec 22
Tracy, CA, 95377
... Member of Internal FDA/ISO Internal Audit team, ADAC Laboratories activities team, and team member/HRIS Advisor for multiple Medical System wide integration tracks. Dionex Corporation Compensation, Benefits & HRIS Analyst 1/96 - 5/99 Served as sole ...
- 2010 Dec 02
Modesto, CA, 95350
... > Worked with FDA to streamline their inspection and approval process of Medline products in the Lathrop facility. > Developed managers and staff to help them achieve goals. 2004-2005 Monster Cable Products, Inc. Manager Order Fulfillment -Brisbane, ...
- 2010 Sep 29
Stockton, CA, 95207
... Managed TQM, Quality Planning, System Analysis, Process Analysis, Quality Improvement, and Statistical Techniques with specific application in the implementation of Management System such as ISO 9001, ISO 13485, ISO 14001, OSHA and FDA regulations. ...
- 2010 Sep 21
Livermore, CA, 94550
... Dublin, CA A pril 2009 to June 2010 $74 Mi llion Full Service Dental Laboratory Senior Manager, Quality Systems Created and staffed the fi rst-ever Quality department for company – staff of 13 Directed the effort to become FDA compliant for medical ...
- 2010 Sep 02
Livermore, CA, 94551
... Drove collaborative R&D to release FDA approved Class I and II devices to market. Monitored multiple markets including mobile cardiac telemetry, ECG Monitoring, minimally invasive glucose monitoring, sleep apnea, respiratory, oral care, mobile ...
- 2010 Aug 28
Escalon, CA, 95320
... Administer safety audits to meet FDA regulations/audits. . Good Manufacturing Practices Coordinator, complete GMP audits and training. Dade Behring Company, San Jose, CA May 1997- June 1998 Customer Service Rep . Nationwide customer interface for ...
- 2010 Aug 25
Antioch, CA, 94531
... Understanding of the FDA and ICH/GCP regulations and how they apply to pharmaceutical manufacturing and labeling PROFESSIONAL EXPERIENCE Clinical Research Associate Certification Program (Aug 2010 - Nov 2010) . Currently working on CRA certification ...
- 2010 Aug 23
Tracy, CA, 95377
... Working on the Philips PACS (Class II FDA Medical Software), ISITE Enterprise and Radiology. . Responsible and accountable for the coordinated management of multiple ISITE API related products directed toward strategic business and other ...
- 2010 Aug 12
Antioch, CA, 94531
... Upon graduation, I found myself working as a field service engineer for an FDA approved medical device company. It was there I honed my field service and troubleshooting knowledge. Working for an FDA regulated, ISO compliant, company on critical ...
- 2010 Jul 06