Responsibilities :
- 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 ( CFR ) and ISO .
- Strong organizational skills, detail oriented.
- Ability to collaborate within an organization across all functional departments ( 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, PowerPoint.
- Experience with D CAD Software SolidWorks.
- Experience working with Engineering change management software & releasing engineering change orders.
Requirements :
- 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.
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