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Quality Engineer
US-IN-Warsaw - 46582
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Warsaw IN area
• Responsible for meeting customer requirements for the manufacturing of surgical instruments and implants or instrument delivery systems from receiving raw material through to the shipping of finished goods.
• Supports the development of and enforces internal systems and procedures to meet ISO standards and FDA quality system regulations.
• Develops and implements inspection/validation techniques necessary to verify products meet requirements at the earliest point in the production process. Specifies and implements new inspection equipment and instructs others in its proper use.
• Supports and implements systems in the areas of SPC, advanced quality, and design and development.
• Practical implementation of systems and procedures for meeting ISO standards and FDA quality system regulations.
• Supervise and train personnel in the inspection of raw materials, in-process and finished goods 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 and customer requirements.

• BA OR BS Engineering
• 3-5 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.

Email resume as MS Word doc attachment direct with targeted salary range or call:

Mike Aquino
PO BOX 2573
North Canton, OH 44720
Phone: 330.305.9223

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