| Looking for Validation roles at San Jose, CA at San Jose, California, USA |
| Email: [email protected] |
| Position 1: Validation Lead Location: San Jose, CA Experience: 7- 8 years Education: Bachelor of Science in Engineering, B.E. / B.Tech. Mechanical Engg. / M.S. Mech. Engg. Title: Team Lead Type of Employment: C2C Visa: H1B, USC Job duties: Process and equipment qualification (IQ/OQ/PQ). Development of test methods for Design V&V, Process Validation, and Production Validation of test methods Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work Authoring/releasing of new test methods and editing/redlining of old test methods Experience working in a regulated and/or medical device environment To define equipment requirements To draft equipment specifications To work on change management and releasing engineering change orders To design process validations and identify critical process parameters related to equipment Working The experience I am looking for is as follows: 6 years of relevant experience in medical device manufacturing. Clean room environment experience Experience with Test Method Validation and/or Measurement System Analysis is preferred. Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred), is a plus. Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485. Strong organizational skills, detail oriented. Ability to collaborate within an organization across all functional departments (e.g. Legal, Regulatory, Operations, Procurement, Clinical Affairs, Operations, Marketing, Quality, etc.) Ability to work to a deadline and to handle multiple tasks simultaneously. Experience with Microsoft Office including Microsoft Word, Excel, and PowerPoint. Experience with 3D CAD Software SolidWorks Experience working with Engineering change management software & releasing engineering change orders. Position 2: Validation Engineer Location: San Jose, CA Experience: 3- 5 years Education: Bachelor of Science in Engineering, B.E. / B.Tech. Mechanical Engg. / M.S. Mech. Engg. Type of Employment: C2C Visa: H1B, USC Job duties: Process and equipment qualification (IQ/OQ/PQ). Development of test methods for Design V&V, Process Validation, and Production Validation of test methods Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work Authoring/releasing of new test methods and editing/redlining of old test methods Experience working in a regulated and/or medical device environment To define equipment requirements To draft equipment specifications To work on change management and releasing engineering change orders To design process validations and identify critical process parameters related to equipment Working The experience I am looking for is as follows: 3 years of relevant experience in medical device manufacturing. Clean room environment experience Experience with Test Method Validation and/or Measurement System Analysis is preferred. Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred), is a plus. Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485. Strong organizational skills, detail oriented. Experience with Microsoft Office including Microsoft Word, Excel, and PowerPoint. Experience with 3D CAD Software SolidWorks Experience working with Engineering change management software & releasing engineering change orders. Keywords: access management rlang California |
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| Sat Sep 07 02:41:00 UTC 2024 |