Technical Line Lead - Medical Devices
On-site · Vandalia, Ohio, United States
Job Summary
Lead and supervise the assembly of wearable medical devices, assign production operators to tasks, balance workloads, and coordinate quick changeovers while ensuring quality and traceability. Train and coach operators on manufacturing processes, equipment use, quality requirements, and SOPs. Ensure compliance with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, GDP, and internal quality policies. Verify accurate production records, enforce safety, lean manufacturing, and 5S. Monitor production performance to maximize efficiency and on-time delivery, identify and escalate quality issues, CAPA and root cause analysis, support continuous improvement initiatives, and perform hands-on line work to maintain production flow.
Required Qualifications
- 2–3 years of experience in medical device manufacturing
- 2–3 years of experience in a Line Lead or leadership role
- Minimum 1 year of experience working in compliance with FDA regulations
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