Process Improvement Manager
- 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.
- Promote a culture of operational excellence and accountability throughout the organization.
- Create and maintain training materials, SOPs, and standardized processes.
- Coach teams to identify waste, solve problems autonomously, and embrace continuous learning.
- 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.
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