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General Summary:
Supervise an inspection team responsible for routine inspections, first article inspections, identifying non-conformance trends, and documentation review. Provide analysis and support for incoming, in-process, and final inspection/testing. Lead Kaizen activities to improve IQC process flow.
Essential Functions:
• Supervise the IQC Inspection team
• Ensure proper workflow for routine inspection, first articles, non-conformances, finished goods testing, and documentation reviews
• Analyze key processes and eliminate waste in the processes listed above
• Perform trending of NCR and identify solutions to prevent recurrence
• Generate tracking metrics for IQC and provide analysis of the results
• Provide guidance, training, and instructions for inspectors
• Create document change orders
• Data entry and filing including computerized MRP transactions
• Perform internal calibrations.
Skill Requirements:
• Experience in a medical device, FDA QSR regulated industry, including ISO 13485 requirements
• Experience inspecting electronics, mechanical and cabled assemblies, as well as printed material and labeling
• IPC 610 620 or equivalent experience
• ANSI Z1.4 Sampling Plans or equivalent experience
• Experience using Excel, Word, Access
• Experience using optical inspection systems
• Strong communications and interpersonal skills
• Ability to work independently with little supervision
• Experience training and instructing others
• Experience handling nonconformance's
• Minimum of 5+ years related experience in medical device industry
Education/Training/Experience Requirements:
• Bachelor degree or equivalent
• 5+ years of experience in inspection and testing experience in the Medical Device Industry
• Minimum of 3 years of experience in a supervisory position
Posted by: KIT List Jobs <jobposting2@kitlist.org>
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