Lead – Quality Assurance Engineer
This position is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. This is a key technical role responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business. The role involves hands-on work in the areas of design, design transfer, manufacturing, distribution, and/or service. Essential Responsibilities 1. Assists in ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
2. Leads, acknowledges, develops, communicates & implements a strategy to ensure compliance.
3. Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site.
4. Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, Lean Manufacturing, 5S, SPC, engineering studies, DOE, Gauge R&R, etc.
5. Leads process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans, including Master Validation Plans (Site Level), Validation Master Plans (Product or Process specific plans), and the development of detailed process flow diagrams that describe critical process interdependencies with respect to process inputs, outputs, risks and impacts.
6. Supports continuous product …cont.
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