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Job #03611

About our client Our client is a rapidly growing medical device company headquartered in Pennsylvania that is focused on the development and marketing of cutting-edge immunoassay diagnostic kits. The company has an experienced management team, a global client base and a corporate culture that is focused on both customer satisfaction and the ongoing advancement of science in their core areas of expertise. Position Location Quality Assurance Manager Pennsylvania Salary Highly competitive package, commensurate with experience Responsibilities 1) Implement and control the quality assurance programs 2) Ensure product reliability, quality and compliance to applicable regulations, (GMP, ISO13485, CE Mark) and internal standards for manufacturing, materials and finished products 3) Manage system and employees to ensure that company quality objectives are being implemented and followed 4) Review complaint, non-conformance, internal/external audit and CAPA programs 5) Manage and conduct internal and external audit programs 6) Ensure systems provide adequate investigation and appropriate process modifications to address findings and satisfy long-term goals of continuous improvement 7) Participate in selecting and applying appropriate statistical tools used in businesses 8) Measure and monitor quality; validate processes and systems facilitate transfer from R&D to manufacturing 9) Substantiate submissions to regulatory bodies 10) Manage resolution of customer quality concerns 11) Ensure validation procedures are in compliance with current regulations 12) Manage policies, SOPs, work instructions and forms associated with the quality system 13) Participate in developing standards and methods for inspection, testing and evaluation of current and new products 14) Oversee Document Control System 15) Participate in and coordinate submission of PMA, 510(k), CE or other applications and monitors yearly renewal of these registrations Requirements 1) BA/BS 2) Minimum 5 years of working experience in the Quality Department of a regulated industry 3) Minimum 3 years of supervisory experience 4) Knowledge of ISO 13485 and GMP