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Key Responsibilities :
Production Support
o Provide day-to-day engineering support for test equipment and processes to ensure smooth production flow.
o Troubleshoot tester issues, perform debugging, and coordinate corrective actions with test engineers and technicians.
o Monitor tester performance, yield, and downtime; implement preventive maintenance and calibration schedules.
Process & Equipment Optimization
o Assist in test process improvements to reduce cycle time, false failures, and yield loss.
o Support continuous improvement initiatives (Kaizen, Lean, Six Sigma) within the test department.
o Collaborate with cross-functional teams to optimize test coverage and efficiency.
Compliance & Documentation
o Ensure test operations comply with ISO 13485, FDA 21 CFR Part 820, and other regulatory standards.
o Maintain accurate records of test activities, equipment logs, and validation reports.
o Support audits and inspections by preparing technical documentation and evidence.
Validation & Qualification
o Assist in executing validation protocols (IQ, OQ, PQ, MQ) for new or modified test equipment.
o Support Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) for tester deployment.
o Participate in correlation studies, GR&R/MSA, and calibration activities to ensure test accuracy.
Team & Supplier Interaction
o Work closely with test engineers, quality engineers, and suppliers to resolve equipment and process issues.
o Provide training and guidance to operators and technicians on proper tester usage and SOP compliance.
Candidate Requirements:
Job ID: 143130861