Logistics Engineer

Logistics Engineer

We are seeking a skilled Logistics Engineer to join our team in Goodfield, IL. The ideal candidate will have strong experience in Corrective and Preventive Actions (CAPA), root cause analysis, and compliance with FDA regulations. This role requires expertise in data analysis, cross-functional collaboration, and investigative reporting to ensure operational efficiency and regulatory alignment.

Key Responsibilities:

• Conduct root cause analysis for each assigned CAPA to determine effective solutions.
• Gather and analyze data to support findings and drive continuous improvement.
• Collaborate with cross-functional teams to develop appropriate corrective and preventive actions.
• Draft and finalize investigation reports with clear justifications under each CAPA.
• Ensure CAPA documentation aligns with FDA 483 resolution needs.
• Participate in internal meetings, provide regular status updates, and address any gaps in the investigation process.
• Support responses to FDA inquiries related to CAPA status as needed.

Requirements:

• 5-7+ years of experience in performing CAPAs and root cause analysis.

• Strong knowledge of FDA regulations, compliance requirements, and CAPA documentation.

• Proficiency in data analysis and reporting.

• Excellent problem-solving and critical thinking skills.

• Strong communication and collaboration skills to work effectively with cross-functional teams.

• Experience in logistics, supply chain, or quality engineering is a plus.