Job Title: Quality Engineer

Location: Eatontown, NJ

· 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. Qualification: · BS Degree in Packaging Science, Mechanical Engineering or Equivalent/MS Engineering · Min 3 yrs. Applicable Experience in packaging engineering, medical devices, pharmaceutical or related industry preferred. Broad knowledge of Mechanical/Manufacturing Engineering.