Quality Engineer

Job Title : Quality Engineer

location : North Haven, CT

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.

• 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.