Assist with the process of monitoring the quality system including records and results from processes and procedures to ensure product Quality and complianceSupport improvement efforts within the Quality systemAssist with setting the standard for QA documentation review regarding quality review thoroughness and timelinessEnsure manufacturing and quality documentation is accurate, maintained, and reflects GMP, procedural and regulatory requirements. Provide constructive feedback to QA and Operations staff regarding documentation qualityMaintain knowledge of current regulatory requirements pertaining to medical device manufacturing and communicates requirements to other associate staffConduct weekly walk-throughs to ensure quality compliance and internal audits to comply with the current ISO standardsEnsure compliance to legal and company requirements with OSHA and other health and safety regulations, as well as continuous improvement of compliance regulationsLead investigations of quality issues as required. Provide analysis and trend information to support these activitiesResponsible for administration of and compliance with the ISO quality system and for administration as required to maintain and renew the certification upon expiration; for coordinating revisions to or required upgrades for the quality system; and for maintaining required Quality Manual, all quality records, process maps and work instructions for the location in Oakwood, GAMaintain quality records procedure and coordinate non-conformance reportingReview and approve non-conformance reports, calculate related cost of quality, coordinate cross-department issues and notify management team of trends or significant issuesAssist with writing and revising quality manual, regulations, policies, and related work instructionsCompile, analyze, and interpret statistical data related to quality operationsResponsible for monitoring outside vendors to insure they are following medmix quality processes
