American Orthodontics seeks a Senior Quality Engineer for our extensive line of orthodontic products. This position will provide comprehensive product and process quality leadership and support throughout the organization.
Collect, analyze, and summarize data, turning it into useful information, then using that information to drive continuous improvement actions.
Establish and implement effective process controls and product test requirements
Select appropriate sampling plans for evaluating product/process quality
Monitor product performance and institute methods to reduce variability
Establish statistical process capability for all manufacturing processes; evaluate precision and accuracy of production equipment.
Perform failure analysis and ensure that timely corrective/preventive action is taken
Collect, review and analyze production data with production and development teams
Use appropriate quality tools (such as 6 Sigma methodologies, DOE, FMEA, and Gage R&R analyses) to solve problems identified during quality assurance activities.
Provide appropriate input to Engineering Change activities
Develop and initiate standards and methods for inspection, testing, and evaluation of products and processes
Provide training and coaching of Inspection personnel
Ensure that appropriate testing, measurement, and analytical equipment and methodology is used for quality assessment; serve as a metrology resource.
Lead root cause investigations, as well as corrective actions in response to customer complaints.
Develop and implement methods and procedures for disposition of nonconforming material; define methods to assess cost of nonconformities.
Conduct audits, including closing out audit findings, creating audit reports and determining proper corrective and preventive actions.
Assist Procurement function with evaluation of prospective suppliers to determine their suitability as long-term business partners. Actively participate in the supplier selection process.
Assist Purchasing in managing suppliers’ performance. Ensure timely resolution of supplier failure, corrective and preventive actions.
Assist with new product launches, including Operations training, drawing interpretation and Control Plan development to ensure that expectations for quality, performance, regulatory compliance, and delivery are met.
Communicate significant issues or developments identified during quality assurance activities and provide recommendations for improvements.
Design and implement methods for process control, process improvement, testing and inspection.
Manage process verification and validation activities according to FDA/CE/Health Canada and all other global regulatory agency requirements.
Report quality issues, trends and losses to management.
BS or BA degree in Mechanical, Industrial, or Manufacturing Engineering, Quality or a related field, with 7 – 10 years’ experience as a Quality Engineer
Demonstrated understanding of metrology, calibration, and inspection techniques.
Demonstrated understanding of data-driven Quality tools such as SPC, CPK, Gage R & R, and problem solving methodologies (e.g. 8D, 6 Sigma, 5-Why), and ability to teach the use of such tools to a wide range of associates.
Demonstrated ability to work and make decisions independently and lead others to the completion of assigned tasks.
Basic understanding of regulatory requirements for medical device design control and manufacturing strongly desired.
Demonstrated ability to communicate effectively both verbally and in written form. Establish good working relationships with all manufacturing, design and material control personnel.
Strong computer skills including QA applications (such as Minitab), word processing, spreadsheets and databases
ASQC CQE certification preferred
Desire to maintain professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, benchmarking state-of-the-art practices, participating in professional societies, and pursuing relevant certifications.
Keyword: Engineer, Quality, Industrial, Engineering, DOE, FMEA
From: American Orthodontics