The desired candidate will have prior direct management experience in a QA role working for a medical device company. Specific experience and responsibilities will include, but not limited to, ISO 13485:2003, FDA compliance, Quality System Regulations, while spearheading and directing the QA function within the company. The QA Manager will be responsible for: quality assurance, incoming inspection, quality assurance, quality compliance and quality engineering. In addition, he or she will also communicate with suppliers, the manufacturing facilities and customers on quality as well as serve as principle contact for Quality Audits, surveys, and corrective actions.
ESSENTIAL FUNCTIONS / MAJOR RESPONSIBILITIES: