Quality Engineer

Provides Quality Engineering Support to manufacturing involving injection molding, precision equipment assembly and calibration service. The responsibilities are as follows:

• Uses and programs CMMs such as OGP Smartflash, Zeiss O-Inspect, Measure mind, Zone3, Calypso, Sprint MVP and Keyence 6100 series instruments. Supports and serves as backup for inspection team when needed.
• Leading 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.
• Supports equipment qualification (IQ/OQ/PQ and Measurement System Analysis)

• 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.

• Performs risk analysis and failure prevention using tools such as DFMEA, PFMEA, DRBFM, Quality Mapping.
• Attends Product Development meetings, advises on quality risks, sets test plans and reviews test results.

• 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.

• A minimum of a bachelor's degree in mechanical engineering.
• 3-8 years' experience as a Quality Engineer in a production environment.