Katalyst Healthcares and Life Sciences
Design Quality Engineer
Katalyst Healthcares and Life Sciences, Warsaw, Indiana, United States, 46580
Roles & Responsibilities: Collaborate with design and engineering teams to ensure quality requirements are integrated into product designs from concept to completion. Conduct Design Failure Mode and Effects Analysis (DFMEA) and risk assessments to identify and mitigate potential design flaws. Support and review design validation (DVP&R) and Design verification plans to ensure product reliability and performance. Review technical specifications and drawings to ensure adherence to quality standards, GD&T, and tolerances. Participate in design reviews and provide feedback on manufacturability, quality risks, and compliance. Establish and maintain Design Control Documentation in accordance with regulatory standards (e.g., ISO 9001, ISO 13485, or AS9100). Support and review Product Development deliverables as per DHF. Investigate and resolve design-related quality issues, ensuring corrective and preventive actions (CAPA) are implemented effectively. Work closely with suppliers to ensure that purchased components meet design specifications and quality requirements. Provide input into continuous improvement initiatives aimed at enhancing product and process quality. Collaborate with External Mfg. and transfer design to Production. Support and Develop Production readiness and create PVE Protocol and report. Review supplier process deliverables and evidence such as PF, CP, PFEMA, MSE, Process capability and Special process etc Familiarity with manufacturing processes, materials, and production workflows relevant to product development. Ability to work collaboratively within cross-functional teams, maintaining strong communication and organizational skills.