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  Familiarized with IQ, OQ and PQ validation phases for molds and equipment.
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  IQ: Confirmation of Drawings (including mold attributes), Equipment, and Procedures (mold setup and operating), mechanical assessment of mold and equipment.
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  Develop inspection programs and instructions for setup/positioning of tooling and parts.
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  Assuring that all product development processes and relevant applicable documentation are executed according to the agreed Product Specific Design and Development Plans.
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  Updating and defining Standard Operating Procedures (SOPs).
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  Familiarized with Gage R&R methodology preferable.
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  Preferably, familiarized with metrology equipment and methods such as calipers, micrometers, CMM, Programmable Vision Inspections Systems.

Requirements

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  Bachelor in Science
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  Experience in FDA regulated industry
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  5 years of experience performing validation lifecycle activities
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  Techical writting skills
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  Read, write, speak and understand English and Spanish