US: Manager, Quality Assurance
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please visit http://sqa.fyicenter.com
Manager, Quality Assurance
* Equivalent Education Level Requirements: Minimum 4 year degree (Bachelorís) in Engineering, Science or Mathematics or related fie
* Must have ability to work occasional alternate shifts
* * 7-10 years Technical Training in Quality and Management with managerial experience.
* * 5 years of working knowledge of Quality Systems, Quality Assurance Principals, cGMP, AQL, FDA 21 CFR 210, 211, 820, and ISO 9001, 2008, ISO 13485:2003.
* * Logical and analytical problem solver, ability to systematically approach problems and develop sound solutions; risk analysis.
* * Strong management, leadership and conflict resolution skills as well as ability to coach and mentor direct staff
* * Working knowledge of OTC, Medical Device, Cosmetic, Disinfectant and ISO requirements.
* * Working knowledge of Quality tools (i.e., Quality Planning, Quality Costs and Assessment, Basic Statistics, Metrology and Calibration, Inspection and Testing, SPC, Sampling Principles and AQL).
* * Must be highly motivated, show initiative, independence and driven to make critical contributions
* * Good verbal and written communication skills, ability to present to all levels of cross functional teams
* * Strong time management and organizational skills
* * Ability to work independently as well as a critical member of diverse teams
* * Ability to prioritize and multi-task setting and meeting aggressive timelines
* * Ability to work comfortably within Microsoft Office platforms; experience with ERP, LIMS and other electronic management systems preferred
To apply for this position, please visit
Team SQAFYI - Software QA Resource FYI