Quality Engineer

Quality Engineer - Eatontown, NJ Job Description & Skill Requirement: • Contribute to continuous improvements in overall product cost and quality. • Participate in DFM / DFA activities assuring that packaging/production processes and equipment are taken into consideration. • Collaborate with Quality Engineering to provide manufacturing support. • Create standardized work and process maps that result in an optimized production system and extended value stream. • Support line validation / qualification activities for including IQ, OQ , MSA and PQ. • Perform root Cause Analysis (RCA), NCR and CAPA responses. • Need to conduct qualification, verification, and validation activities to produce medical devices. • Work with CFT teams in troubleshooting problems on the production floor. • Design, develop, testing, and validate equipment and processes; analyze and interpret process models and recommend process improvements. • Drive the execution of various validation and PFMEA activities as per the project plan • Application of statistical and analytical methods such as SPC, SQC and DOE. • Contributor to the Capital Expense Request (CER) process, specify cost for Packaging/Labeling/ sealing equipment with consideration to product standard cost targets and capacity demands. • Provide detailed engineering analysis and documentation in the management of material disposition, process updates, NCR's and CAPA. • Execute Site acceptance test and Factory acceptance test based on North Haven • Execute Validation Gap analysis of various product families based in Medtronic • Plan and initiate CDPs associated with the various validation activities • Co-ordination with stakeholders • Provide detailed engineering analysis and documentation in the management of material disposition, process updates, NCR's and CAPA.