Job Details | Senior Engineer

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Confidential

 Location: Chicago, IL 60602 Document ID: A7173-04JB
Ad Number: 000055366701 Published on: 2013-05-0105/01/2013 Job Type: Regular

Job Schedule:Full-time
Published in: Chicago Reader
2013-05-30
 

Senior Engineer

Classified As seen in Chicago Reader


Untitled


SR. ENGINEER (INTERNAL title Quality Mgr North America): Manage and maintain responsibility for the local Quality Management System at Brainlab; Execute Quality System requirements as defined by Brainlab AG with focus on local practice including both FDA and Health Canada requirements; manage implementation of corrective and preventive actions; Evaluate all reported incidents; perform internal and external audits on behalf of both Brainlab AG and Brainlab Inc.; Manage and provide education to Brainlab Inc. employees regarding quality management and the quality system including focus on complaint handling processes; Manage a local post-market surveillance system; Manage and ensure local documentation control including any implementation of 820 CFR Part 11; Local Quality Representative for Brainlab including corresponding FDA manufacturer registration; Coach other QM personnel on general regulatory requirements as well as on workflow organization and communication; Communicate continuously with senior management in alignment with Brainlab Corporate Strategy. Required: Bachelors degree in Biomedical Science or Engineering; 5 yrs exp in quality mgt role and with medical devices; Must relocate to Westchester, IL area; Proficient in the use of PC software applications including Microsoft Office; Experience with Six Sigma or Total Quality Management; Permanent authorization to work in the United States. Mail cover letter and resume to N. Bandukwala, HR, Brainlab, Inc., 3 Westbrook Corporate Center, Ste 400, Westchester, IL 60154.
     
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