Develop and implement reliability analysis, design, validation and assessment methods to support successful new product introductions and or sustaining product changes
Provide quality leadership to new product development teams in the areas of design control, design verification and validation, design transfer, process validation, risk management, and specification development
Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders
Provide ongoing quality engineering support throughout the product life cycle. Provide support to development, engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs strategies and requirements. Ensure product development and validation programs meet requirements of FDA and ISO when applicable