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US-Arizona-Flagstaff: QA ENGINEER
To see other opportunities,
please visit http://sqa.fyicenter.com
Date: 20-Jun-2008
QA ENGINEER
Requirements
Bachelor’s degree in an applicable science or engineering (or a two-year degree plus significant medical device experience or significant medical device experience in a Quality Assurance role). Must have at least ten years medical device or pharmaceutical industry experience in quality assurance and a demonstrated track record of successful Quality Assurance leadership. The successful candidate will also have demonstrated experience in successful partnership with other leadership functions (Business, Engineering, Manufacturing, etc), and been involved in FDA and Notified body audits, preferably as the audit lead. Additional documented experience in the following areas is also required: Demonstrated excellent written and oral communication skills, strong interpersonal skills, conflict resolution, quality systems implementation and maintenance; statistics; Design control, GMP/Quality System Regulations; ISO 9000/EN46000/ISO13485, vendor and process auditing (including certified auditor training); product/process/software validation; generation of change control documents; document control; and receiving inspection. Basic computer literacy is also required. Desirable: Advanced degree(s) in an applicable science, engineering and/or business. Experience in PMA
This position also requires that the Associate is involved in developing policies and procedures which affect operational and compliance status and working with quality management representatives as appropriate. This individual will also provide additional mentorship to quality assurance associates (and others), assist in leading facility efforts to address product issues, provide direction to the implementation of effective corrective actions and review the results of monitoring of post-implementation effectiveness. Additional responsibilities include a focus on design control and other activities in support of new product development, systems enhancement (including software implementation and validation), working with engineering to enhance process yields, compliance auditing, working with procurement and engineering to select and approve vendors, associate training, and demonstrating strong support for our culture. Further responsibilities may include: Initiation of change documentation, advisory roles supporting various teams (such as raw materials inspection, document control, maintenance and calibration, environmental monitoring and control, etc.); initiation of change documentation; preparation of quality reports and presentations; review of complaints.
For more information, please write to us.
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
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