Quality Engineer
4 weeks ago
Job Title: Quality Engineer
Location: North Haven, CT (Onsite)
Job 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 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.
MAKING THE INDUSTRY'S BEST MATCHES
DBSI Services is widely recognized as one of the industry's fastest growing staffing agencies. Thanks to our longstanding experience in various industries, we have the capacity to build meaningful, long-lasting relationships with all our clients. Our success is a result of our commitment to the best people, the best solutions and the best results.
Our Story:
Founded in 1995
Privately Owned Corporation
Managing Partner Business Model
Headquartered in New Jersey
US Based Engineers Only
Collaborative Team Approach
Methodology and Process Driven
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Top performing engineers are the foundation of our business. Our priority is building strong
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