Quality Engineer - Healthcare

The Quality Engineer - Healthcare is responsible for assisting with the implementation, management, and administration of the quality management system and ensuring products are manufactured per quality and regulatory requirements and industry best practices.                                                                                                                                                            Main Accountabilities and tasks Assist with the process of monitoring the quality system including records and results from processes and procedures to ensure product Quality and compliance.Supports improvement efforts within the Quality system.Assist with setting the standard for QA documentation review regarding quality review thoroughness and timelinessEnsures manufacturing and quality documentation is accurate, maintained, and reflects GMP, procedural and regulatory requirements.  Provides constructive feedback to QA and Operations staff regarding documentation quality. Maintain knowledge of current regulatory requirements pertaining to medical device manufacturing and communicates requirements to other associate staff. Conducts weekly walk-throughs to ensure quality complianceEnsure compliance to legal and company requirements with OSHA and other health and safety regulationsMakes recommendations to improve quality of operationsConducts internal audits to comply with the current ISO standardsLead investigations of quality issues as required.  Provides analysis and trend information to support these activities.Participates in continuous improvement objectives to assure compliance with regulations.Performs other duties as assigned by managementMaintain and apply knowledge of current policies, regulations, and industrial processes for Medmix USA.Responsible 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, GA.Must have an understanding of FDA regulations i.e. 21 CFR Part 4Maintains quality records procedure and coordinates non-conformance reporting.Reviews and approves non-conformance reports and responds, calculates related cost of quality, coordinates cross-department issues, notifies managers and management team of trends or significant issues.Assist with writing and revising quality manual, regulations, policies, and related work instructions.Compiles, analyze, and interprets statistical data related to quality operations.Responsible for monitoring outside vendors to insure they are following m1edmix quality processes.Additional projects as assigned