As 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.
Responsibilities Report on the performance of the quality system to site management Coordinate product non-conformance process and reports (NCRs) Support product/process changes and new product launch Responsible to own and/or support Corrective and Preventive Actions (CAPA), relative to the specific area of responsibility and/or products Monitor the effectiveness of quality improvements and validation activities as part of the CAPA process requirements Manage quality assurance activities related to processing of materials through final product inspection, testing, and release May 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 activities Quality 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. Requirements Bachelor of Science in Engineering or related science field, or technical equivalent
Minimum 3+ years of experience in the Quality Assurance field working with ISO 13485, FDA Quality System Regulations, and Medical Device Directive requirements
Minimum 1 year utilizing corrective and preventive action (CAPA) system, in compliance with US federal and international regulatory standards relating to medical devices
Minimum 1 year experience in Nonconforming Product Management
Minimum 1 year experience in Complaints investigation
Minimum 1 year Utilization of root cause analysis tools, including fishbone diagrams, fault tree analysis, 5 Whys, Is/Is Not
Process validation; statistical process control, root cause investigation, and use of problem-solving tools
Basic knowledge of Lean Manufacturing and Continuous Improvement concepts and tools
Nice to have, but not required Experience working in an electro-mechanical assembly manufacturing environment
Specialized Training: FDA GMP training; Basic statistical including trends, pareto and other basic charting techniques
Training with basic statistical including trends, pareto and other basic charting techniques
Desirable Lean Six Sigma Green Belt Certification
Horizon 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.
