Operations Engineer

Center Valley, PA - The Operations Engineer supports Field and Support Services' current and future Quality Management System and promotes quality improvements through initiating corrective and preventive action activities jointly with all departments to improve customer satisfaction. The Operations Engineer will function as Project Coordinator on more complicated projects, as defined by the Manager, by providing technical information to other project participants, recommending cost effective procedures, tracking and maintaining implementation dates and documenting completed projects. This candidate must be able to offer solutions concerning quality discrepancies and process improvements based on data collection, trend analysis and reporting activities. The Operations team works closely with Medical Products Repair Group, Financial, Business Development Center and RA/QA departments in support of process improvement initiatives, work instruction and document review for Field and Support Service Organization. The Operations Engineer will initiate and perform routine and periodic assessment activities by working closely with Field and Technical Assistance Center personnel to ensure compliance with the quality management system and associated regulations.  EOE M/F/D/V. Assist in process validation and New Product / Repair Introduction activities, including standards development, and identify needs for Field and Support Services. Support calibration and maintenance of inspection measuring and test equipment. Support document control and ensure coding for special projects for traceability and budget. Conduct periodic product, process and systems audits and support preventative and corrective action activities to ensure that specified requirements are met. Develop Engineering project check sheet to identify start and finish dates and measure progress. Provide progress report to FSS Operations Manager and to other project participants. Coordinate corrective and preventive action activities (CAPA) related to RA/QA direction. Analyze service records with appropriate statistical methodology in support of tracking and measuring the completion of corrective and preventive action activities (CAPA). Represent Field and Support Services (FSS) in Change Control Board and provide input and recommendations to maintain standards. Develop and implement training plans for FSS staff partnering with Corporate Training and/or RA/QA. Provide required training to FSS staff when needed. Ensure recording of training. Develop and maintain quality trend reporting and analysis in support of Field and Support Services. Perform other related duties as assigned.

(ONLY QUALIFIED CANDIDATES WILL BE CONSIDERED) Bachelor's degree preferred, associate's degree with applicable job experience minimally required, preferably within applicable science, engineering, or industrial technology field At least 5 years experience in Biomedical or IT Field and /or Field Service Knowledge of FDA regulations desirable Training experience and strong presentation skills preferred Professional technical communicator preferred Effective written and verbal communication skills Able to function as a team player Excellent detail/problem solving skills Able to multitask, well organized, analytical, logical, practical Possess a high degree of self reliance, initiative, creativity and personal organization Ability to work flexible hours Ability to travel by car/plane for long periods of time (including overnight travel) Computer literate with experience in Microsoft Office A+ or Net+ Certifications desirable

If interested, please apply online at http://track.jobviper.com/ViewJob.asp?id=551379-3-203