Job Description

Position Summary:

The Continuous Improvement Specialist will be responsible for driving operational excellence, process optimization, and efficiency improvements within a medical device contract manufacturing environment. This role will focus on identifying and implementing process improvements, ensuring compliance with industry regulations, and delivering cost reductions while maintaining high standards of quality and safety. The ideal candidate will possess a Lean certification and have a strong background in process improvement methodologies.

Key Responsibilities:

• Lead and facilitate continuous improvement initiatives across various manufacturing operations to improve efficiency, reduce scrap and waste, and enhance product quality.
• Analyze current processes, systems, and workflows to identify opportunities for improvement and standardization.
• Utilize Lean tools (e.g., Kaizen, 5S, Value Stream Mapping, Root Cause Analysis) to identify inefficiencies and implement corrective actions.
• Develop/Charter/Facilitate process improvement projects and team (PIT Teams) aimed at reducing cycle time, improving product yield, and lowering operational costs.
• Collaborate with cross-functional teams, including production, Quality Assurance, engineering, and supply chain, to drive continuous improvement across the organization.
• Conduct process audits, collect and analyze data to measure the success of improvement projects and report progress to management.
• Train and mentor team members on Lean principles, methodologies, and best practices to foster a culture of continuous improvement.
• Assist in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions to ensure process consistency and compliance with regulatory standards (e.g., FDA, ISO).
• Support the implementation and monitoring of key performance indicators (KPIs) to track operational performance and ensure alignment with company goals.
• Ensure all process improvements comply with Good Manufacturing Practices (GMP) and other regulatory requirements relevant to medical device manufacturing.

Qualifications:

• Lean certification (e.g., Lean Six Sigma Green Belt, Black Belt, or similar) is required.
• Bachelor's degree in Engineering, Manufacturing, Operations Management, or a related field (or equivalent experience) is preferred.
• At least 3-5 years of experience in continuous improvement roles, preferably within a medical device or regulated manufacturing environment.
• Strong knowledge of Lean principles, Six Sigma methodology, and process improvement tools.
• Experience with data analysis tools and techniques, including statistical analysis and process control.
• Excellent problem-solving skills and the ability to work with cross-functional teams to implement improvements.
• Strong communication, presentation, and training skills.
• Knowledge of regulatory requirements and standards such as FDA 21 CFR Part 820, ISO 13485, and GMP is highly desirable.
• Ability to thrive in a fast-paced, dynamic environment with a focus on results.

Physical Requirements:

• Ability to work in a manufacturing environment, which may include walking, standing, and occasionally lifting up to 25 lbs.
• Ability to work with and review process data and reports from various departments.

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