Design Assurance: Quality Planning (i.e., new product development, design excellence, and design transfer). Ensures that all design control and production / process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements
Design and development planning, design input, design output, design review, design verification, design validation, design transfer, design changes, and design history file maintenance.
Champions and drives Lifecycle Risk Management throughout the business unit
Design risk management: Assure that appropriate risk management tools (i.e., FMEA's) are utilized for all programs and projects and that the tools used are consistent with applicable regulatory standards and industry practices.
Design control excellence: Continuous monitoring and improvement of the design control program/process to ensure best-in-class processes.
Change control: Ensure change control projects are comprehensively evaluated and executed per the change control process.
B.S. in Engineering, Engineering Technology, Science a minimum.
American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred
Minimum 3 years of experience with FDA regulated industry, preferably on product development programs.