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Quality Engineer

4 months ago

Grand Rapids, United States Katalyst Healthcares and Life Sciences Full time

Responsibilities: Implement Quality systems for production and engineering. Material Review Board (MRB) experience or exposure. Collect and evaluate quality data to identify process improvement opportunities. Work with production to create corrective action plans to address process failures. Review supplier manufacturing processes, collaborate with team members on process improvement and value enhancement opportunities. Regularly communicate with Engineering, Manufacturing Engineering, and Supply Chain team members internally to identify opportunities for quality and productivity improvement. Collect, maintain, and report on quality performance metrics. Participate in Engineering Change meetings to ensure thoroughness and compliance. Warranty analysis and drive improvements through interdepartmental collaboration Manage CAPA process and drive improvements utilizing available quality data Supplier Management- Review supplier manufacturing processes, collaborate with suppliers on process improvement and value enhancement opportunities. Partner with design engineering for verification and design intent Provide support and analysis on special projects as assigned. Bachelor's degree (B.A. or B.S.) in Manufacturing, Industrial, or Mechanical Engineering, or related field from an accredited college or university or equivalent. 3 years of Quality Engineering, Reliability Engineering, or Test Engineering experience. Experience working in an industrial manufacturing environment. Requirements: Knowledge of mechanical, pneumatic, hydraulic, and electrical systems and components. Knowledge or experience in regulated environment (ISO9001, ISO13485, AS9100, etc.) Proficient in quality analysis tools such as 8D, SPC, PFMEA, DFMEA and others. Strong problem-solving skills with the ability to teach basic problem-solving techniques and facilitate problem solving team events. Knowledge of fabrication-based quality control methods, tools, and techniques. Strong engineering analysis skills, as well as data analysis and reporting. Strong communication skills both written and verbal, presentation skills, and team building skills. Manages time effectively, remains organized in all circumstances. Self-motivated with a high level of initiative.