Role: Quality Engineer Location: Ponce , Puerto Rico Description: 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 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.