Quality Engineer

Responsibilities

• Uses and programs CMMs such as OGP Smartflash, Zeiss O-Inspect, Measuremind, Zone3, Calypso, Sprint MVP and Keyence 6100 series instruments.
• Serves as backup for inspection team when needed.
• Supports and leads teams in problem solving with manufacturing quality problems, using root cause analysis and 8D or similar methodology.
• Analyzes quality data and generates reports using Minitab, JMP or similar to perform Gauge R&R, capability analysis, statistical confidence testing, DOE.
• Utilizes SPC to monitor production.
• Determines sampling plans and advises inspectors in measurement, inspection and testing of materials.
• Manages discrepant material.
• Supports equipment qualification (IQ/OQ/PQ and Measurement System Analysis).
• Performs supplier audits.
• Utilizes an understanding of metrology and uncertainty calculations to make decisions about calibration and to support customers.
• Responds to customer quality assurance departments' complaints concerning product failures, service calibration errors using SCARs/VCARs or 8D reports.
• Attends Product Development meetings, advises on quality risks, sets test plans and reviews test results.
• Performs risk analysis and failure prevention using tools such as DFMEA, PFMEA, DRBFM, Quality Mapping.
• Compiles and writes training material and conducts training sessions on quality control activities.
• Maintains a working knowledge of the appropriate ISO standards, CE and FDA regulations and new developments in testing and examination methods of processes, materials, and products.
• Leads audits of company and supplier processes to ISO9001:2008 and/or ISO13485. Audits company service centers to ISO17025.

Requirements

• Mechanical Engineering Degree
• 3-8 years as a Quality Engineer in a production environment
• Experience in Root Cause Analysis
• Injection Molding experience preferred
• Experience with Minitab preferred