SQAFYI - Software QA Resource - FYI

US-CA-SanFrancisco: Manager/Director of Quality Assurance

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

To apply for this position, please visit this Website.

Thank you,
Team SQAFYI - Software QA Resource FYI

US-CA-SanFrancisco: Manager/Director of Quality Assurance