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More>Detail-oriented Medical Device Manufacturing Technician with 5+ years of experience in cleanroom assembly, equipment setup, in-process inspection, and GMP-regulated production. Strong background in SOP compliance, batch record documentation, troubleshooting, and lean manufacturing support. Consistently helps improve yield, reduce downtime, and maintain audit-ready quality standards in FDA-regulated environments.
- Assembled catheter and delivery system components in ISO Class 7 cleanroom environments, meeting daily production targets while maintaining 98.7% first-pass yield across assigned work orders.
- Performed equipment setup, line clearance, and in-process inspections following SOPs and GMP requirements, helping reduce documentation errors by 22% over twelve months.
- Troubleshot minor fixture, tooling, and material flow issues during production runs, cutting average line stoppage time by 18% through faster root-cause identification.
- Completed batch records, device history records, and nonconformance documentation with high accuracy, supporting successful internal audits and zero critical findings in 2023.
- Assisted with training four new technicians on assembly methods, contamination control, and safe material handling, improving onboarding consistency and reducing rework events.
- Supported assembly, packaging, and labeling of sterile single-use devices, consistently achieving schedule adherence above 95% during high-volume monthly production periods.
- Conducted visual inspections and basic functional checks using calibrated tools, identifying defect trends early and helping lower scrap rates by 14% year over year.
- Followed preventive maintenance schedules and escalated equipment abnormalities promptly, contributing to a 16% improvement in uptime on a critical sealing station.
- Collaborated with quality and engineering teams during process validations and document revisions, ensuring updated work instructions were implemented without disrupting output.
Selected by site leadership to support transfer of two catheter assembly processes into a new production cell completed on schedule.
Recognized for maintaining complete batch records and device history documentation through three consecutive internal and customer audit cycles.
Contributed to technician training standardization that reduced new-hire time to independent operation by approximately two weeks.
Current credential.
Current credential.
Coco Panda
Hands-on training in electronics, quality systems, troubleshooting, calibration, and regulated manufacturing environments.
Detail-oriented Medical Device Manufacturing Technician with 5+ years of experience in cleanroom assembly, equipment setup, in-process inspection, and GMP-regulated production. Strong background in SOP compliance, batch record documentation, troubleshooting, and lean manufacturing support. Consistently helps improve yield, reduce downtime, and maintain audit-ready quality standards in FDA-regulated environments.
- Assembled catheter and delivery system components in ISO Class 7 cleanroom environments, meeting daily production targets while maintaining 98.7% first-pass yield across assigned work orders.
- Performed equipment setup, line clearance, and in-process inspections following SOPs and GMP requirements, helping reduce documentation errors by 22% over twelve months.
- Troubleshot minor fixture, tooling, and material flow issues during production runs, cutting average line stoppage time by 18% through faster root-cause identification.
- Completed batch records, device history records, and nonconformance documentation with high accuracy, supporting successful internal audits and zero critical findings in 2023.
- Assisted with training four new technicians on assembly methods, contamination control, and safe material handling, improving onboarding consistency and reducing rework events.
- Supported assembly, packaging, and labeling of sterile single-use devices, consistently achieving schedule adherence above 95% during high-volume monthly production periods.
- Conducted visual inspections and basic functional checks using calibrated tools, identifying defect trends early and helping lower scrap rates by 14% year over year.
- Followed preventive maintenance schedules and escalated equipment abnormalities promptly, contributing to a 16% improvement in uptime on a critical sealing station.
- Collaborated with quality and engineering teams during process validations and document revisions, ensuring updated work instructions were implemented without disrupting output.
Selected by site leadership to support transfer of two catheter assembly processes into a new production cell completed on schedule.
Recognized for maintaining complete batch records and device history documentation through three consecutive internal and customer audit cycles.
Contributed to technician training standardization that reduced new-hire time to independent operation by approximately two weeks.
Current credential.
Current credential.
Coco Panda
Hands-on training in electronics, quality systems, troubleshooting, calibration, and regulated manufacturing environments.
