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Quality Assurance Specialist K2M
The purpose of this position is to ensure that all purchased, in-process, and completed product is manufactured within specifications regarding configuration, dimension, aesthetics, contamination, surface finish, packaging/ labeling, and material properties to meet the company?s quality and GMP requirements.Under supervision, performs visual, dimensional, and functional inspections of raw material, components, in-process, and final product based on documented K2M specifications (i.e. drawing, procedure, work instructions, etc.).
Perform label inspections
Fill out and process quality reports and entering into the computerized quality reporting database.
Review and maintain all inspection documentation.
Transact parts in JDE
High school Diploma or GED; some college or technical training preferred. Minimum of: 1 years? experience in a Quality Inspector capacity and 2 years? Mechanical Inspection experience, or an equivalent combination of education and experience.
Ability to read complex mechanical blueprints.
Experience with ANSI Y14.5 Geometric Tolerancing.
Statistical sampling plan ANSI Z1.4 (Previously MIL Std. 105E) experience preferred.
Working knowledge of GMP compliance for Class II Medical Devices.
Must have extensive knowledge using measurement equipment such as calipers, micrometers, optical comparator, video measurement equipment, plug gauges, etc.
Understanding of thread specifications and classifications.
Basic understanding of machining processes
FDA QSR (cGMP) knowledge required, ISO 13485 also preferred.
Must be able to accurately document and maintain records.
Excellent English written and verbal com
| Location: | Malvern, PA United States |
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K2M
Investors: New Science VenturesAll Jobs: at K2M
| Web Site: | www.k2m.com |
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| Headquarters: | 751 Miller Drive, SE Suite F-1 Leesburg, VA 20175 United States |
| Industry: | Medical Devices and Equipment |
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