Manufacturing Quality Systems Engineer

hace 5 días


Ponce, Ponce, Puerto Rico Intellectt Inc A tiempo completo

Job Overview

We are seeking a highly skilled Manufacturing Quality Systems Engineer to join our team at Intellectt Inc.

About the Role

This is an exciting opportunity for a detail-oriented and analytical professional to contribute to the development and implementation of quality systems in our manufacturing process.

Key Responsibilities

  • To contribute to continuous improvements in overall product cost and quality.
  • Participate in Design for Manufacturability (DFM) and Design for Assembly (DFA) activities to ensure 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, including IQ, OQ, MSA, and PQ.
  • Perform root Cause Analysis (RCA), NCR, and CAPA responses.
  • Conduct qualification, verification, and validation activities to produce medical devices.
  • Work with Cross-Functional Team (CFT) members in troubleshooting problems on the production floor.
  • Design, develop, test, 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.
  • Apply statistical and analytical methods such as SPC, SQC, and DOE.
  • Contribute to the Capital Expense Request (CER) process, specifying costs 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, NCRs, and CAPAs.
  • 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 Corrective and Preventive Actions (CAPAs).
  • Coordinate with stakeholders.

Requirements

To be successful in this role, you will need:

  • A Bachelor's Degree in Mechanical Engineering or equivalent.
  • At least 3 years of applicable experience in packaging engineering, medical devices, pharmaceuticals, or a related industry.
  • Broad knowledge of Mechanical/Manufacturing Engineering.

Benefits

We offer a competitive salary and benefits package, including:

  • A salary range of $80,000 - $110,000 per year, depending on experience.
  • A comprehensive health insurance plan.
  • A retirement savings plan.
  • Generous paid time off and holidays.

Location

Ponce, Puerto Rico.



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