Quality/ Validation Engineer - Katalyst Healthcares & Life Sciences
South Plainfield, NJ 07080
About the Job
Responsibilities and Requirements:
- Education: Bachelor of Science in Engineering, B.E. / B.Tech. Mechanical Engg. / M.S. Mech. Engg.
- 4+ 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.
- 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.
Source : Katalyst Healthcares & Life Sciences
