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Provide focused, technical, hands-on engineering assistance regarding V&V requirements of medical device processes, materials, equipment and methods including project management, process design, document generation (IQ, OQ, PQ, SOPs, WIs and ETSs), critical process parameter development, protocol execution and summary reports. Successfully contribute to cross-functional project teams in all areas of device cleanliness and manufacturing V&V work such as material testing, specification development, process capability studies, research, and investigation and process/test documentation.

Exactech Inc

Senior Quality Engineer, Validation

Such a training program must have been conducted in an operating health care system and included: Assignments providing a knowledge of basic health system administration philosophies, practices, and procedures, and basic government administrative policies and requirements; Practical assignments providing an opportunity to apply health system administration skills and principles (as the individual progresses, work assignments must be characteristic of the grade level to which he or she is assigned); and Oversight by an experienced health system administrator with periodic evaluation of the individuals progress and appropriate adjustment of the training program. The incumbent provides technical and administrative supervision to a section of two (2) Health Systems Specialists, GS-0671-13 for data analysis; two (2) Nurse (RN) Informaticists; three (3) Health System Specialists, GS-0671-12/13 for program and administrative oversight, direction, and management; one (1) Administrative Officer, GS-0341-9/11 for program management; and two (2) Program Support Assistants, GS-0303-7 for administrative support.

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