Description
Duties include:- Develops master test plans that encompass design verification, design validation and process validation activities.
- Creates test methods and protocols, validates them when necessary; and performs and documents such tests in reports.
- Identifies and manages risk through the development process using risk management tools
- Designs, implements and continuously improves receiving inspections, in-process. inspections and/or manufacturing process monitoring methods using SPC or other statistical methods.
- Provides input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
Experience:
- BS degree in Engineering
- Previous medical device experience (5-10 years).
- Experience developing test plans for design validation and verification.
- Comprehensive knowledge of FDA standards and ISO 13485 Principles.
- Six Sigma Black belt is a plus*
To find out more about Real please visit www.realstaffing.com