IT Engineer (Supplier Quality Engineer Supplier Production …, South Bend

Job Summary:

Analyze and review the effectiveness of preventive and corrective actions.

Evaluate root cause investigations based on established processes.

Take accountability and ownership of quality metrics, including the maintenance and review of leading and lagging indicators of quality.

Develop, interpret, and implement appropriate process monitoring and control methods consistent with the level of process and product risk.

Collect data and conduct various analytical and statistical analyses to support process improvements and daily operations.

Document, justify, and assess proposed process changes to ensure they do not increase risk levels beyond the capability of current controls or lead to potential non-compliance with required standards, such as QSRs.

Evaluate the need for risk mitigation techniques based on product classification, defect types, defect frequency, severity, patient risk, process capability, and process controls. Assess the effectiveness of these techniques on previously implemented improvements.

Collaborate with Manufacturing/Process Engineering, R&D, and Regulatory departments to resolve process issues and implement changes.

Apply expertise in process control tools, statistical sampling, and other analytical techniques to optimize product quality and production flow.

Identify, analyze, and manage risk throughout the product life cycle using FMEA and other risk management tools.

Lead product and process Corrective and Preventive Action (CAPA) investigations from issue identification to solution implementation and effectiveness monitoring.

Execute equipment qualification and process validation projects.

Must-Have Skills:

Root Cause Analysis & Corrective Actions Strong expertise in investigating quality issues and implementing preventive and corrective actions.

Process Monitoring & Control Experience with Statistical Process Control (SPC), process validation, and tracking quality metrics.

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 in 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, Design of Experiments (DOE), statistical sampling, and data analysis methods.