Quality System Manager responsible for ensuring quality of products during and after process. Responsible for recording, analyzing, and presenting all data related to performance metrics including corporate and departmental measurable objectives.  Actively involved in continual improvement techniques and ideas to boost morale, educate employees, analyze processes, improve productivity and quality of work.  Responsible for conducting ongoing formal training on all new and current employees on the quality system and any changes to policies, procedures, work instructions and quality plans.  Responsible for authoring, publishing and training controlled technical documentation for all new processes (to include quality assurance) in every department under the organization. Responsible for presenting quarterly/periodic review of business data to the executive management team and to record and distribute minutes, coordinate creation of action items and all CAPA and manage action completion and check for effectiveness.  Responsible for liaising with customer/certification auditors and ensuring that the organization is compliant with applicable aspects of the ISO standard and FDA regulation.  Manage, review and investigate (if needed) the calibration and test records of all test equipment  Active member of safety committee responsible for monitoring facility, corporate policy and employees for compliance to OSHA standards and general safety rules.  Responsible for managing control of all external documentation (500+ items)