Description
- Provide leadership for process improvement, and change management support to internal processes and external suppliers in resolving quality, productivity, and routine technical issues related to new and existing products during all phases of the product life cycle.
- Promotes success through development of methods and arguments for achieving company objectives while adhering to Quality/Regulatory requirements and assures compliance to internal and external standards for product development and manufacturing.
- Provide Quality Engineering leadership for the transfer of product manufacturing from acquired companies/products into the Irvine Plant or out-sourcing Irvine Plant assemblies to ISO 13485 certified companies.
- Responsible for creating and get cross-function buy-in on validation strategies and testing guidance for implementation of process changes that directly improve quality, cost, and supply of product.
- Designs and install quality process sampling systems, procedures, and statistical techniques.
- Will be responsible for ensuring the product is manufactured in accordance with applicable industry standards, regulatory requirements, and customer requirements. In the case where corrective action is needed, this person will lead mitigation activities.
- Provides guidance on the training program, conducts training, and supervises other engineers and inspection personnel in execution of Quality tasks and production.