The Quality Engineer provides support for quality improvement through empirical testing and by identifying testing methods and sampling plans. Additionally, the position will assist in the development of statistical analysis and trending in order to maintain the Quality Management System. Reports to the Quality Manager.

• Analyze quality performance utilizing statistical and analytical tools and methods
• Implement methods to inspect, test, and evaluate the reliability and accuracy of processes, products, and production equipment
• Develop and establish quality procedures and systems for checking plans, quality trends, capability studies, and verification/validation activities
• Ensure process control documents adhere with set requirements
• Assist in on-time processing of non-conforming components
• Assist material-review disposition process through failure analysis and corrective actions
• Coordinate with suppliers and internal/external customers relating to quality trends, performance and corrective action
• Verify conformance and productivity of quality engineering system through supplier audits and surveys
• Initiate programs to enhance supplier performance
• Interact with product development committees to inspect and review engineering releases
• Review all product quality aspects like planning, manufacturing methods, and process specifications
• Interact with manufacturing and engineering teams to optimize documentation related to quality and inspection checks
• Develop and establish quality processes to establish and provide evidence for Device Master Record
• Assist manufacturing scrap performance evaluation and management

Education

• Bachelor’s degree in engineering or science field

Experience

• Five years of previous experience in a quality engineer, quality assurance, or related role
• Experience with lean manufacturing principles

Skills

• Excellent verbal and written communication skills
• Ability to analyze problems and strategize for better solutions
• Understanding of ISO 9001, 140001, etc. implementation
• Proficiency using Microsoft Suite (Excel, Access)

Personal

• Demonstrated ability to lead courageously, maintaining a strong position amidst opposition to resolve critical issues, and ability to navigate through the complexity
• Ability to interact with all levels of the organization
• Business agility to manage complexity, change, and uncertainty; flexibility; nimbleness
• Hands-on, energetic, and a “can do” attitude