Perform detailed, accurate, and compliant engineering documentation for Master Validation Plans, PFMEA, Qualification and all Validation activities(IQ ,OQ,PQ and TMV)
Perform detailed engineering analysis and documentation in the management of material disposition, process updates, ECRs and CAPA
Assist in Design of Experiments to improve process/product.
Perform analyses and provide reports to management.
Work with other departments to resolve issues related to material and process quality, including FMEA, DOE, SPC.
Develop Control Plans, Work Instructions and other documents as needed to effectively manage product/process quality.
Work directly with suppliers to prevent or correct discrepant material.
Compile and issue monthly/weekly reports to management.
Assign primary responsibilities and tasks to ME department.
Other duties as assigned with or without accommodation.
Strong communication, manufacturing process, product industrialization and leadership skills
Analyze and chart statistical and process data using Minitab, MS Excel, or equivalent
Complete on time project updates, project hours, development plans, self-assessments, and successful completion of all training requirements
Working Knowledge of Six Sigma
Working knowledge of GDT
Working knowledge of DFMEA, PFMEA , and Risk Tools
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