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Resumes 31 - 40 of 114 |
Austin, TX
... Working knowledge with US FDA current Good Manufacturing Practices(cGMP’s), ISO 13485, ISO 14971. Initiation, documentation and assisting execution for IQ, OQ, and PQ activities. 510k submissions and 21 CFR 820 guidelines on Validation, Design, Risk ...
- 2019 Feb 20
Austin, TX
... Experience in testing medical devices in FDA compliance environment. Experience in testing Client/Server and Web-Based applications. Experience in Embedded Testing Experience in reviewing and analyzing Business Requirements and writing detailed Test ...
- 2018 Nov 13
Austin, TX
... Led business separation testing for LMS system with interfaces to FDA regulated manufacturing Quality Systems. Project Manager separating global integrated PeopleSoft HR system between two rival companies. Separated Human Resources, Payroll, ...
- 2018 Jul 14
Austin, TX
... A Winning Record Federal Campaigns Advocated for following policies Quality of Life Act Palliative Care & Hospice Education & Training Act FDA statute limiting tobacco firms marketing to minors & reveal ingredients on cigarette packaging. Texas ...
- 2018 May 15
Austin, TX
... Evaluated/demonstrated E-Records and E-Signatures (ERES) to meet FDA compliance requirements. Data Migration & Validation strategy. Performed Data conversion through Data Loader. Designed customized reports & Bar code labels. Bar Code printer ...
- 2018 May 09
Austin, TX
... company MRB Lead GD&T drawing Gauge R&R Inspection plans Calibrations Inspection tools Validations Supplier interaction IQ/OQ/PQ Controlled documents Audits: In-Process & Systems Device History Records FDA Audit Efficiency Team Leader, SME & Intent ...
- 2017 Dec 27
Austin, TX
... Educational Background Bachelor of Science, Civil Engineering (EIT Certificate) University of Puerto Rico, Mayagüez, Puerto Rico Training/Seminars OSHA 30-hour Training for Construction - Validation Certification - 22-hour FDA Lockwood Greene ...
- 2017 Sep 26
Austin, TX
... Extensive experience and training in utilizing FDA regulated procedures and detailed documents while analyzing products in a certified cGMP/GLP quality control facility. Induce changes in composition of substances by introducing heat, light, energy, ...
- 2017 Sep 11
Pflugerville, TX, 78660
... Supported external and internal audit as FDA, TUV, Japan, etc. Medtronic Team Member 2 (1994 – 2002): Worked in Manufacturing Cell as a manufacturing operator of Medtronic leads and Sterile Pack. Worked in Final Pack Area packing the final lead, ...
- 2017 Aug 19
Austin, TX
... Implemented company-wide roll out of new food safety standards and ensured that all the units were in compliance with FDA and Health Department requirements. Negotiated prices and terms with suppliers and vendors in addition to managing equipment ...
- 2017 Aug 08