Responsibilities:
• Ensure compliance with safety rules, HR policies, Quality policies, and employee guidelines.
• Maintain a cGMP compliant environment, operate within FDA guidelines for 21CFR820 manufacturing, and ensure compliance to ISO 13485
• Support the NPI team in executing pFMEA remediation actions across manufacturing lines.
• Review and analyze process risks identified in pFMEA documents.
• Track remediation activities, action owners, and closure status using project trackers.
• Assist in collecting evidence and documentation to support risk mitigation implementation.
• Support cross-functional meetings involving Manufacturing, Quality, Operations, and Engineering teams.
• Help update process documentation, including work instructions, process flow diagrams, and control plans.
• Prepare project status reports and summarize key findings for management review.
• Participate in continuous improvement initiatives aimed at reducing process risks and improving product quality.
• Collaborate with Cross-Functional Teams: Work closely with design, development, testing, and production teams to gather requirements, provide updates, and ensure seamless integration of builds.
• Documentation and Record Keeping: Maintain comprehensive documentation (Protocol and Report) of build requests, processes, and outcomes. Ensure all records are up-to-date and easily accessible.
• Perform other duties as required