Role: Quality Engineer

Location: Ponce, Puerto Rico

Duration: 12 Months

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 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.