Continuous Improvement Manager

Mirion Technologies, Inc.; Norfolk (VA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading medical device manufacturer is seeking a Continuous Improvement Manager to implement and drive strategies for operational excellence. This role requires the oversight of Lean and Six Sigma methodologies to enhance product quality, improve cost efficiency, and ensure regulatory compliance with FDA and ISO standards. The ideal candidate will have over 5 years of experience in a regulated manufacturing environment and a strong background in continuous improvement tools. This position offers opportunities to mentor staff and present outcomes to senior leadership.

Qualifications

• 5+ years of experience in continuous improvement within a regulated manufacturing environment.
• Strong working knowledge of CI methodologies.
• Experience in FDA-regulated or ISO 13485 environments.

Responsibilities

• Lead and execute continuous improvement strategies across the organization.
• Facilitate workshops and mentor staff on CI tools.
• Ensure processes comply with FDA regulations and ISO standards.

Skills

Lean

Six Sigma

Problem-solving

Analytical skills

Communication skills

Change management

Education

Bachelor’s degree in Engineering, Manufacturing, Operations, or related field

Tools

Minitab

JMP

Job description

The Continuous Improvement Manager is responsible for leading, developing, and executing strategies to drive operational excellence across the medical device manufacturing organization. This role champions Lean, Six Sigma, and problem‑solving methodologies to improve product quality, reduce waste, enhance cost efficiency, and ensure regulatory compliance. The Continuous Improvement Manager partners closely with Manufacturing, Quality, Engineering, Supply Chain, and Regulatory Affairs to standardize processes and cultivate a culture of continuous improvement.

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.

Process Optimization & Waste Reduction

• 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.

Quality & Regulatory Compliance

• 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.

Project Management

• 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.

Culture & Capability Building

• 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.

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.

Equal Opportunity Employer
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