Quality Engineer - Medical Device Manufacturing

Work for a stable and growing Medical Device Manufacturer based in Orange County!

Growth potential!
Work with a great team...
Competitive Pay and Benefits

The Quality Engineer supports new product development, lean implementation, process capability improvement, daily production support, project management, technical data interpretation/analysis, and quality system management.

Principal Activities

• Conduct product appraisal/Source inspections as required.
• Interface with customer site Customer Quality issues associated with procured parts to drive solutions, minimize customer impact, and eliminate issue/s.
• Drive manufacturing process capability improvements through variation reduction, error-proofing, and implementation of statistical process control.
• Provide leadership to other functional areas such as planning/purchasing on problem solving teams to drive root cause analysis and Corrective/Preventive Action (CAPA) plans.
• Work with sourcing group on supplier selection.
• Develop process flow charts/diagrams and Process Failure Mode Effects Analysis (PFMEA).
• Use lean and six sigma tools to drive process and product variation reduction.
• Conduct and participate in the internal and external quality system, process, and product audits.
• Develops and establishes problem/process root cause and definitive corrective action plans necessary to reduce Supplier Scrap, Rework and Repair costs.
• Supplier Quality Improvement Projects – Work with procurement team to understand issues (data/fact driven), formulate documented plans, execute, continuously report results to leadership.
• Supply Chain Performance – Ability to manage/publish supplier performance metrics, develop projects to improve processes and incorporate automation into our day to day workflow.

CANDIDATE REQUIREMENTS

• Product Appraisal – Expert interpreting and conducting product inspections.
• Experience: Minimum of 2 years of progressive experience in quality and manufacturing
• Six sigma tools and methodology; green belt or black belt experience is a plus.
• Lean manufacturing practices to improve product/process quality.
• Excellent problem-solving skills aimed at identifying and correcting the root causes of problems
• Demonstrated ability to create and implement statistically valid control plans and audit plans

Education: Bachelor of Science degree in technical field AND/OR extensive verifiable experience in lieu of degree.
ASQ Certified- Certified Quality Auditor/ Certified Quality Manager