Quality Engineer
Quality Engineer
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Salary Not Disclosed
1 Vacancy
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) Client 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; analyse 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/Labelling/ 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 Clients and CAPA.
- Execute Site acceptance test and Factory acceptance test based on North Haven
- Execute Validation Gap analysis of various product families based in Healthcare
- 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 Clients and CAPA.
- 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.
Employment Type
Full Time
