Quality System Engineer

RESPONSIBILITIES Ensure Quality System conforms to the Quality System Regulations (QSR), ISO 13485, MDD, MDR, CMDR, PAL, corporate and sector requirements Assist with the implementation of Quality System Improvements in conjunction with Director of Quality.

Prepare and complete of Document Change Orders including training as requested Manage the system for implementing changes to Quality System procedures based on the implementation of Sector SOP and Corporate Policy changes Plan, coordinate, and present Quality System training and/or new employee quality system orientation training including Complaint Handling Awareness Compile Quality System trend data, prepare presentation of the data at Quality Review Meetings and coordinate Quality Review and Quality Management Review meetings Prepare monthly sector metrics for CAPA, Environmental Monitoring and other Quality System processes as requested Create and maintains Quality System files and databases to ensure information is accessible and accurate (ex.

CAPA Tracking Log) Support and coordinates corporate, internal, and external regulatory agency audit activities as assigned Monitor and track the implementation of corrective action/preventive action (CAPA) as result of internal and external audits (FDA, TUV, etc.) and reports progress to management on a routine basis Perform internal quality audits and maintain audit schedules QUALIFICATIONS 2 years QS(Quality Systems) or QC (Quality Control)related experience in FDA/GMP regulated industry Completed Bachelor’s degree Ability to read and comprehend simple instructions, short correspondence, and memos.

Ability to work with mathematical concepts such as probability and statistical inference Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists