• Must have thorough understanding and working knowledge with Validation Principles and Concepts, Design Controls Processes in accordance with regulatory requirements (e.g., Quality ISO standards, ASME BPE, CE, BPOG, REACH, ROHS, WEEE etc.)
· Supports the New Product Introduction (NPI) team with deployment of Quality Engineering tools for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle. Work with multi-functional product development teams.
· Experience in Supplier selection and qualification of critical suppliers in support of NPIs.
· Working knowledge in development and creation of material specifications in support of NPIs.
• Works independently to support the comprehensive completion of risk management (FMEA), Design and Process Verification activities for products and processes.
• Assists in the development and validation of appropriate test methods for product and process performance.
• Proficient in utilizing Lean and Six Sigma methodologies as appropriate to achieve optimal results.
· Review of Equipment IOPQ’s in support of commercial operations.