AMETEK Paragon Medical
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Job description: 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.