JD :: Validation Engineer :: Location: San Jose, CA, USA
Raj Malhotra
<rajm@simplisoftwaresolutions.com>Title: Validation Engineer
Location: Location: San Jose, CA, USA
Experience: 4 - 5 years
The experience I am looking for is as follows:
- 3 years 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, PowerPoint.
- Experience with 3D CAD Software SolidWorks
- Experience working with Engineering change management software & releasing engineering change orders.
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
Education:
Bachelor of Science in Engineering, B.E. / B.Tech. Mechanical Engg. / M.S. Mech. Engg.
Please fill all the details its mandatory:
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Thanks & Regards
Raj Malhotra
Technical Recruiter
E: ra...@simplisoftwaresolutions.com
P: +1 (508)-471-5167, +1 (989)-218-5282 (WhatsApp Number)
A: 20 Dunia Lane, Northborough, MA, 01532
W: https://www.simplisoftwaresolutions.com/
L: linkedin.com/in/raj-malhotra-371130238
USA / Canada / Europe / England / India
