US-CA-SanFrancisco: Manager/Director of Quality Assurance To apply for this position, please visit this Website. http://sqa.fyicenter.com/jobs/99660045_Manager_Director_of_Quality_Assurance.html To see other opportunities, please visit http://sqa.fyicenter.com Date: 01-Mar-2013
Manager/Director of Quality Assurance * Take ownership of the Quality Management System (QMS) * Maintain current knowledge of federal and state regulations regarding QSR, ISO, good clinical practices, and quality assurance issues. * Lead the effort to obtain ISO 13485 certification. * Thoroughly support Regulatory Affairs efforts. * Initially, perform all QA-related roles. * Hire, train, and manage quality assurance staff as Channel Medsystems grows. * Identify and manage suppliers and consultants to support QA activities. * Implement and maintain Standard Operating Procedures (SOPs). * Oversee employee QMS training. * Interface with the FDA and State Department of Public Health during inspections. * Proactively champion QA issues. * Manage the Approved Supplier List (ASL) and conduct supplier audits as required. * Qualify and maintain the CER. * Periodically inspect the facility to ensure QSR compliance. * Oversee calibration and maintenance for all equipment, instruments and tools. * Maintain DMR and LHR files. * Thoroughly document all issues related to QA, QSR, and ISO compliance. * Establish department budget and schedule * Proactively communicate QA-related issues to management. * Excellent oral and written communication skills. * 8+ years experience in the quality system function in the medical device or biotech industry * Experience working in small teams (start-up experience a plus) * Excellent attention to detail Thank you, Team SQAFYI - Software QA Resource FYI http://sqa.fyicenter.com -- You received this message because you are subscribed to the Google Groups "Software Quality Assurance Center" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at http://groups.google.com/group/software_qa_center?hl=en. For more options, visit https://groups.google.com/groups/opt_out.
