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Engineer Iiiso13485, Fda 21Cfr, Gmp/Gdp Medical Newport News, Va Ref

ESR Healthcare
Newport News, VA
January 15, 2022


Engineer IIISO13485, FDA 21CFR, GMP/GDP Medical Newport News, VA ref

Experience level: Associate Experience required: 2 Years Education level: Bachelor’s degree Job function: Engineering Industry: Mechanical or Industrial Engineering Compensation: View salary Total position: 1 Relocation assistance: Yes Visa : Only US citizens and Greencard holders


Apply engineering knowledge to plan, develop, validate, and test manufacturing processes to meet FDA and ISO requirements. Qualify parts, equipment, fixtures, test plans to guarantee adherence to customer and regulatory requirements.

Review criteria with potential suppliers and support the development of quotes for parts, fixtures, and equipment.

Coordinate equipment installations with Facilities and/or manufacturing departments.

Monitor the status of projects including equipment and process qualifications, change orders, and product launches.

Establish project plans and provide feedback to appropriate personnel.

Analyze production data to identify trends and develop appropriate action items.

Lead customer and supplier technical communications.

Research sources for domestic and international parts.