Quality Engineer

 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.

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.