Quality Engineer - (New London, WI)

Summary: The QTI Group is partnering with a global supplier of flexible packaging to hire a Quality Engineer. Reporting to the QA Manager, the Quality Engineer will ensure compliance with company Quality Management Systems and customer qualifications in accordance with ISO 13485, and provide quality engineering support to manufacturing. Responsibilities: Assist with process validations (IQ, OQ, & PQ) and product validations as per customer qualifications and ISO-11607 Support manufacturing units with analyzing failures, preventive and corrective action processes related to both internal and external issues Facilitate Failure Mode and Effect Analysis (FMEA) Perform Design of Experiments (DOE) Track, trend and report quality metrics Carry out continual improvement activities to enhance the quality system, such as 5S, Kaizen lean methods, etc. Provide support for the implementation and sustaining of statistical process controls (SPC) Provide support to engineering change order process