Job Title:  Quality Engineer

Essential Job Functions:

• Assists in the development and implementation of systems and processes that foster continuous improvement for product development and/or manufacturing.
• Responsible for ensuring cell processes are correctly base lined and controlled. Known variability is to be accounted for through selection & frequency of inspection, sampling plans, or implementation of SPC.
• Completes the implementation and performance of gage R&R, process capability studies, design of experiments, and summaries as required to improve quality and to provide required deliverables to customers.
• Ensures processes released with use of SPC where applicable and/or promote the utilization of SPC.
• Provides SPC & ongoing monitoring of SPC.
• Investigates deviations, OOS, complaints, returns, recalls, and field alerts.
• Supports the Material Review Board (MRB) for internal non-conformances and customer returns.
• May lead or verify effectiveness of corrective and preventive actions (CAPAs).
• May liaise directly with customer representatives.
• Supervise and train personnel in the inspection of raw materials, in-process and finished goods by using statistical sampling techniques and precision measuring instruments to check conformance to requirements.
• Verify that all production procedures have been followed and the records such as Device Master Records and Device History Records are maintained per FDA & customer requirements and company requirements.

Education & Experience:

• Bachelor’s Degree in Engineering or related field with a minimum of two years’ experience with tight tolerance measurement systems in machining applications.
• Blueprint reading, GD&T, and a working knowledge of short-run process control methods.
• DOE, ISO standards, and FDA quality system regulations.
• Previous medical device experience preferred.