IT Engineer

Experience level: Mid-senior                   Experience required: 6 Years              Education level: Bachelors degree        Job function: Information Technology Industry:  Information Technology and Services   Total position: 1          Relocation assistance: No                 Visa sponsorship eligibility:  No

Job Description:

• Supplier Production Parts Approval (SPPA)
  Analyze/review the effectiveness of preventive and corrective actions.
• Review root cause investigation according to an established process.
• Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
• Develop, interpret, and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
  
• Collect data and execute/conduct various analytical/statistical analyses and interpretations as part of process improvements and day-to-day support.
  

• Document, justify, review, or analyze whether a proposed change to a process will not enhance the risk level in some way beyond the capability of current controls or whether a change will result in potential non-compliance to a required standard such as the QSRs
  
• Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine the effectiveness of these techniques on previously implemented improvements
• Interface with Manufacturing/Process Engineering, R&D, and Regulatory departments to resolve process issues and implement changes.
  
• Apply knowledge of process control tools, statistical sampling, and other analytical techniques to maximize the quality and flow of products through the production line.
  
• Identify, analyze, and manage risk through the product life cycle with the use of FMEA and other risk management tools.
  
• Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through the implementation of solution and effectiveness monitoring.
  
• Execute equipment qualification and process 

Must Have:.

• Root Cause Analysis & Corrective Actions Strong understanding of investigating quality issues and implementing preventive/corrective actions.
• Process Monitoring & Control Experience with statistical process control (SPC), process validation, and quality metrics tracking.
• Risk Management Proficiency in Failure Modes and Effects Analysis (FMEA) and other risk assessment techniques.
• Quality Standards & Compliance Knowledge of industry standards such as ISO 9001, IATF 16949, AS9100, or QSRs (Quality System Regulations).
• CAPA (Corrective and Preventive Action) Experience facilitating CAPA investigations and implementing long-term solutions.
• Process Validation & Equipment Qualification Understanding of validation protocols (IQ/OQ/PQ) for manufacturing equipment and processes.
• Manufacturing & Supplier Quality Interface Ability to collaborate with suppliers, process engineers, and regulatory teams to resolve quality issues.
• Analytical & Statistical Tools Proficiency in Six Sigma, DOE (Design of Experiments), statistical sampling, and data analysis methods.