Continuous Improvement Manager

Key Responsibilities

• Develop and implement sitewide continuous improvement strategies aligned with business goals.
• Facilitate Kaizen events, value stream mapping, root cause analysis (RCA), and other improvement workshops.
• Mentor and train employees at all levels in CI tools, Lean thinking, and structured problem-solving.
• Establish systems to monitor, measure, and report CI progress and KPIs.
• Analyze production and quality performance to identify opportunities for efficiency, cost reduction, and throughput improvements.
• Drive initiatives using DMAIC, PDCA, 5S, standard work, and other Lean/Six Sigma methodologies.
• Collaborate with cross-functional teams to streamline workflows, enhance equipment utilization, and improve material flow.
• Ensure improvement projects support and strengthen compliance with FDA regulations (21 CFR Part 820), ISO 13485, and internal QMS requirements.
• Partner with Quality teams to reduce defect rates, CAPA recurrence, and manufacturing variation.
• Use data-driven approaches to ensure process capability, validation support, and risk mitigation.
• Plan, execute, and sustain medium-to-large scale CI projects, ensuring milestones are met.
• Develop business cases, project charters, and ROI analyses to justify improvement initiatives.
• Present CI updates, outcomes, and recommendations to senior leadership.

Required Qualifications

• Bachelor’s degree in Engineering, Manufacturing, Operations, or related field.
• 5+ years of experience in continuous improvement, operational excellence, or process engineering within a regulated manufacturing environment (medical device preferred).
• Strong working knowledge of Lean, Six Sigma, and structured problem-solving tools.
• Experience working within FDA-regulated or ISO 13485 environments.
• Demonstrated success leading CI projects and cross-functional teams.
• Excellent analytical, communication, facilitation, and change-management skills.
• Familiarity with statistical software (Minitab, JMP, etc.).
• Experience with automation, digital manufacturing tools, or Industry 4.0 technologies.