Location : ,
Location: Goodfield IL
Logistics Engineer
Responsibilities will include:
• Conducting root cause analysis for each assigned CAPA.
• Gathering and analyzing data to support investigation findings.
• Collaborating with cross-functional teams to develop appropriate corrective and preventive actions.
• Drafting and finalizing investigation reports with clear justifications under each CAPA.
• Alignment of CAPA documentation with FDA 483 resolution needs.
• Participate in internal meetings, provide status updates, and address any gaps during the investigation process.
• Supporting responses to FDA inquiries as it pertains to CAPA status, as needed.
REQUIREMENTS:
5-7+ years of experience performing CAPAs