Description:
This company is a local orthodontics company who has been around for 40 plus years in Franklin, IN. Proudly design and manufacture our products in the USA, and are registered to sell them in 93 countries. Supporting many product lines used for orthodontic clients.
This position will support the Quality Manager for on going process validations for product and equipment. As the company grows they are implementing new machines which need to be validated. The Quality Engineer will work closely with operations and engineering to reduce scrap and drive continuous improvement activities to reduce customer complaints and lower the response time. Will be working with two quality technicians and quality supervisor. Will have a team of quality control personal supporting him/her as well. This position will investigate internal and external quality issues and identify root cause, using data analysis, data trending and periodic reporting. This position will perform product and process validations (IQ, OQ, PQ). Majority of this role will be working with process and equipment validations on both product and process.
• Ensure product and process validations are completed.
• Perform discrepant material disposition with guidance.
• Recommend inspection plans, test methods, and standard operating procedures.
• Conduct sample size determination, statistical analysis, root cause analysis and applicable training.
• Actively contribute to various manufacturing projects such as process development, cost reduction and quality improvement initiatives.
• Collect and trend quality indicators for monthly and quarterly reviews.
• Support documentation development including writing specifications for manufacturing or scientific test results.
• Support in management, implementation, and documentation of IQ, OP, PQ.
• Participate in cross-functional teams in continuous quality improvement projects.
• Participate in the Internal Audit process and assist in addressing observations.
• Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
Additional Skills & Qualifications:
Nice to have:
Dental experience-braces, wires, brackets
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