Quality Engineer

Company:  I3 INFOTEK INC
Location: North Haven
Closing Date: 31/10/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description

Responsibilities:

  • 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.


Qualifications:

  • 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.

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