US-CA-SanFrancisco: Manager/Director of Quality Assurance
To see other opportunities,
please visit http://sqa.fyicenter.com
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
Team SQAFYI - Software QA Resource FYI