Sr. Quality Engineer

Profile

An operations quality engineer supporting new product development and design transfer activities. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. This position will lead and provide strategic direction on design for manufacturability, risk management evaluation as well as process validation. Also provides support to the Manufacturing organization to facilitate efficient operations within the production area, to optimize existing processes, and to ensure that production goals are met. Monitors performance of equipment, machines and tools and corrects equipment problems or process parameters that produce non-conforming products, low yields or product quality issues. Main Responsibilities ? Execute and support on-time completion of Design Control Deliverables ? Accountable for Process Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities ? Lead or support Risk Management activities from product Development through Commercialization ? Support design and manufacturing test and inspection method development, and lead method validation activities ? Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps ? Responsible for compliance with applicable Corporate and Divisional Policies and procedures. ? Leads technical activities for new or improved products or process, for current programs, next generation programs and to meet strategic goals and objectives of the company. ? Presents findings and recommendations. ? Analyzes and solves problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems which require novel and new innovative approaches or a major breakthrough in technology.
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