Quality Engineer
CurrentRoles and Responsibilities 1. Ensuring compliance and conducting CAPA. • Conducting Internal Audits • Conducting External Audits 2. Assist customers in resolving product issues. • Complaint investigation/problem solving • Customer training • Design improvements • Special orders 3. Assist during new product development. • Validation support for product, processes, packaging and sterilization • Develop inspection plans and procedures 4. Conducting failure analysis of products and processes. • Problem solving efforts • Reliability design improvements • Product failure trending • Training 5. Develop part and product inspection methods and sampling plans • Statistical process control • Incoming part/product inspection criteria • Automated testing • Functional gauging • Productivity improvements 6. Support vendor management issues. • Problem solving • Auditing • Inspection techniques/equipment • Training 7. Working with purchasing on part qualifications • First article review, analysis and paperwork completion • Production part approval process analysis and paperwork completion