Design Quality Engineer
Katalyst HealthCares & Life Sciences
- Warsaw, IN
- Permanent
- Full-time
- 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.