HCG Quality Engineer

3 weeks ago


Atlanta, United States Horizon Controls Group Full time

Job DescriptionAs the Quality Engineer, you are responsible for product quality assurance and quality engineering. You will provide technical oversight and maintain quality systems that are effective and comply with federal, state, local, and other applicable international regulations, and standards. You will also ensure compliance with site policies and procedures.ResponsibilitiesReport on the performance of the quality system to site managementCoordinate product non-conformance process and reports (NCRs)Support product/process changes and new product launchResponsible to own and/or support Corrective and Preventive Actions (CAPA), relative to the specific area of responsibility and/or productsMonitor the effectiveness of quality improvements and validation activities as part of the CAPA process requirementsManage quality assurance activities related to processing of materials through final product inspection, testing, and releaseMay supervise quality control functions (receiving, in-process inspection, product final release, calibration program, and complaint evaluation)CAPA: Drive quality data analysis (fishbone diagrams, pareto analysis, etc.) and coordinate activities to make product and process improvements. Review sources of Quality Data including process yields and complaint data to identify any necessary CAPA activitiesQuality Systems: Develop and maintain quality assurance procedures and work instructions regarding inspection and data gathering/analysis.Process Controls: Monitor product quality through inspection, testing, and auditing. Ensure Device History Records are maintained in compliance with FDA requirements.Metrics Management: Work with operating entities to establish and maintain procedures for inspection, process control, data analysis and product conformance. Issue reports on KPIs to appropriate management.Product Surveillance: Assist in Product Complaint evaluations and investigations.Special Quality Projects: Identify, own, and lead Quality projects in collaboration with other site resources, primarily focused in the improvement of Quality processes and efficiency, in alignment to Operational Excellence and business goals.RequirementsBachelor of Science in Engineering or related science field, or technical equivalentMinimum 3+ years of experience in the Quality Assurance field working with ISO 13485, FDA Quality System Regulations, and Medical Device Directive requirementsMinimum 1 year utilizing corrective and preventive action (CAPA) system, in compliance with US federal and international regulatory standards relating to medical devicesMinimum 1 year experience in Nonconforming Product ManagementMinimum 1 year experience in Complaints investigationMinimum 1 year Utilization of root cause analysis tools, including fishbone diagrams, fault tree analysis, 5 Whys, Is/Is NotProcess validation; statistical process control, root cause investigation, and use of problem-solving toolsBasic knowledge of Lean Manufacturing and Continuous Improvement concepts and toolsNice to have, but not requiredExperience working in an electro-mechanical assembly manufacturing environmentSpecialized Training: FDA GMP training; Basic statistical including trends, pareto and other basic charting techniquesTraining with basic statistical including trends, pareto and other basic charting techniquesDesirable Lean Six Sigma Green Belt CertificationHorizon Controls Group is a company rooted in human-centric values. We are dedicated to fostering diversity, equality, inclusion, and a deep sense of belonging within our organization. We firmly believe that by creating an environment where our diverse team members can freely exchange ideas and thrive, we are better equipped to serve both our organization and our diverse global clientele. We empower our staff to feel valued, connected, and capable of making meaningful contributions to the communities they are part of, both personally and professionally. Above all, we want each employee to be proud to be a member of Horizon Controls Group.


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