CIRS (Computerized Imaging Reference Systems, Inc.) · 7 hours ago
Process Improvement Manager
Norfolk, VA
Full-time
Onsite
Senior Level
5+ years expComputerized Imaging Reference Systems is focused on enhancing operational excellence in the medical device manufacturing sector. The Continuous Improvement Manager will lead strategies to improve product quality, reduce waste, and ensure compliance with regulatory standards while collaborating with various departments.
ManufacturingMedicalMedical Device
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
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
Qualification
Required
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
Company
CIRS (Computerized Imaging Reference Systems, Inc.)
CIRS, with Sun Nuclear, powers better Quality Management for Better Care in Radiation Therapy and Diagnostic Imaging.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2021-11-11Acquired
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