Quality Lead
Katalyst HealthCares & Life Sciences
Quality Engineer
We are seeking a Quality Engineer to support enterprise Advanced Product Quality Planning (APQP) tools, processes, and continuous improvement initiatives. The consultant will provide functional and technical support for engineering applications used in Requirements Management (RM), Design and Process FMEA, Process FMEA (PFMEA), and Control Plans.
Roles & Responsibilities
- Support the functionality, performance, maintenance, and enhancement of enterprise engineering tools supporting Requirements Management, FMEA, and Control Plans.
- Gather and analyze feedback from stakeholders and end users to identify tool and process improvement opportunities.
- Document business and functional requirements and support prioritization of system enhancements.
- Coordinate project activities, track deliverables, manage action items, and monitor risks and issues.
- Communicate project status, issues, and progress to business stakeholders, IT teams, vendors, and functional organizations.
- Collaborate with internal IT teams and external software vendors to troubleshoot application issues, validate solutions, support software releases, and implement approved enhancements.
- Support application testing, user acceptance testing, defect tracking, and release activities.
- Develop and maintain process documentation, user guides, training materials, and knowledge-transfer resources.
- Provide user support and training to promote consistent and effective adoption of APQP-related tools and processes.
- Support the development, deployment, maintenance, and continuous improvement of Power BI dashboards and reports.
- Analyze data and reporting requirements to improve visibility into product development performance and process effectiveness.
- Serve as a subject matter resource for Requirements Management, FMEA, Control Plans, tool usage, data quality, and APQP-related processes.
- Identify root causes of tool, process, and data issues and recommend practical corrective and continuous improvement actions.
- Support data quality, process alignment, user adoption, and standardization initiatives across the enterprise.
- Manage multiple priorities and deliverables in a project-oriented environment while responding effectively to changing business needs.
Education & Experience
- Bachelor's degree in engineering, Computer Science, Information Technology, or a related technical field is highly preferred.
- Equivalent combination of education, technical training, and relevant professional experience may be considered.
- 8 years of professional experience working with cross-functional engineering, quality, IT, and business teams.
- Experience collaborating with software vendors and end users to troubleshoot issues and implement solutions.
- Experience documenting business/functional requirements, supporting testing, and managing software enhancements or releases.
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