Fisec Global
Validation Engineer Medical Devices Manufacturing Systems
Fisec Global, Skaneateles Falls, New York, us, 13153
Job Title and Position
Validation Engineer Medical Devices Manufacturing Systems Location:
Skaneateles Falls, NY No. of opening:
1 Job Description
Author/Develop Risk Assessment, User Requirement Specification, Validation Plan, IQ/OQ/PQ, SOP, FMEA, RTM, and Validation Report. Perform IQ/OQ/PQ test execution for manufacturing equipment. Experience in Test Method Validation, Gage R&R, Minitab, and Process Validation. Hands-on experience in GAMP 5, FDA 21 CFR Part 11, Data Integrity, ALCOA requirements. In-depth understanding of FDA regulations (21 CFR Parts 820, 210/211). Collaborate with cross-functional teams (R&D, Quality, Manufacturing) to define validation requirements and risk-based testing strategies. Investigate and resolve software or system-level issues found during validation or manufacturing use. Experience in ATE system validation in the medical device industry. Measurement System knowledge. Systems Experience
Ultrasonic Washer Barcode Scanner Bio-Burden Hood Auto Cannula Sorter Air Blockage Tester LASERMIKE / Bench Top Laser Mike FARREL MIXER W/CONTROLLER AND PULLER Puller/Cutter Rubber Slicer EXTRUDER W/ WATER BATH Flow Tester Printex/ Zebra Printers/ Printronix Printer/ Image Pouch Printer Bladder Sorter Auto Machine Automatic Tube Set Assembly Machine Snap Cap Welding Machine Longford Labeler/ Universal Labeling System/ Labeling Machine Herrmann Welder Uson Leak Tester/Two Up Tester/Coiled Fill Port Tester Battery Simulator Battery Module Communication Test Fixture Keypad misuse test fixture
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Validation Engineer Medical Devices Manufacturing Systems Location:
Skaneateles Falls, NY No. of opening:
1 Job Description
Author/Develop Risk Assessment, User Requirement Specification, Validation Plan, IQ/OQ/PQ, SOP, FMEA, RTM, and Validation Report. Perform IQ/OQ/PQ test execution for manufacturing equipment. Experience in Test Method Validation, Gage R&R, Minitab, and Process Validation. Hands-on experience in GAMP 5, FDA 21 CFR Part 11, Data Integrity, ALCOA requirements. In-depth understanding of FDA regulations (21 CFR Parts 820, 210/211). Collaborate with cross-functional teams (R&D, Quality, Manufacturing) to define validation requirements and risk-based testing strategies. Investigate and resolve software or system-level issues found during validation or manufacturing use. Experience in ATE system validation in the medical device industry. Measurement System knowledge. Systems Experience
Ultrasonic Washer Barcode Scanner Bio-Burden Hood Auto Cannula Sorter Air Blockage Tester LASERMIKE / Bench Top Laser Mike FARREL MIXER W/CONTROLLER AND PULLER Puller/Cutter Rubber Slicer EXTRUDER W/ WATER BATH Flow Tester Printex/ Zebra Printers/ Printronix Printer/ Image Pouch Printer Bladder Sorter Auto Machine Automatic Tube Set Assembly Machine Snap Cap Welding Machine Longford Labeler/ Universal Labeling System/ Labeling Machine Herrmann Welder Uson Leak Tester/Two Up Tester/Coiled Fill Port Tester Battery Simulator Battery Module Communication Test Fixture Keypad misuse test fixture
#J-18808-Ljbffr