ASHEBORO, GA 27203
TRC has an immediate need for a Quality Engineer to work as a permanent employee, directly for our customer in Asheboro, North Carolina. They are a worldwide service provider and manufacturer of high-quality products. Experience in the Medical Device industry is highly preferred.
The position reports to the Quality/Regulatory Affairs Manager and involves activities related to the Quality System for both existing and new product launched. The position will interface with all disciplines within the Plant and also the end customer.
Essential Duties and Responsibilities
• Take customer calls and/or complaints and analyze problems.
• Inquire/question customers and determine decision. Notify plant and give them a heads up. If the problem is serious, call upper management.
• Identify problem, relay containment to customer and form a correction action team. Identify root cause and undertake corrective action policy. Write corrective action and report back to the customer.
• Ensure corrective actions are implemented on the floor and also present corrective action in-person, to the customer.
• Must become familiar with customer processes.
• Revise OMI's based on quality issues.
• Conduct internal audits.
• Write/revise standard operating procedures/work instructions.
• Create templates to support quality management functions.
• Review and disposition requests for Customer Returns of rejected materials.
• Manage 3rd party sort activities initiated at Customer's site.
• Analyze data retrieved from sorts or line and utilize data in various ways (cost estimating, inspection effectiveness, new business product design, PFMEA, Lessons Learned, etc.
• Plans and conducts the analysis, inspection, design, test, and/or integration to assure the quality of assigned product or component.
• Performs quality engineering reviews of design documentation for compliance with stated requirements, including vendor quality manuals and company quality records.
• Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes, (i.e., Minitab).
• Reviews all purchased products or components and provides input to the decision of whether to accept the product and future purchases from the vendor with our SDE on corrective actions requested of our suppliers.
• Documents data obtained during all quality assurance activities, consistent with company policies and procedures.
• Develops new approaches to solve problems identified during quality assurance activities.
• Communicates significant issues or developments identified during quality assurance activities and provides recommended process improvements to management.
• Prepares reports to communicate involvement and results of quality assurance activities.
• Prepares and presents technical and program information to team members and management.
• Directs technical and administrative workers engaged in quality assurance activities.
• Maintains a working knowledge of government and industry quality assurance codes and standards.
• Negotiates with customer regarding quality acceptance of non-conforming materials when appropriate (obtain buy-offs on questionable rejects). Support Customer if OEM approval of non-conforming material is required (go in as a “team”).
• Should be proficient in Microsoft Office applications such as Microsoft Project, Excel, PowerPoint, Word and CAD applications. Internet usage of web-based customer sites is required.
• Working knowledge of Plexus.
• Ongoing instruction (CEs) to keep thought process “fresh.”
Education and Job Experience Requirements
Bachelor's Degree in Engineering Technology (Quality Engineering a plus) or a related discipline, plus two years of relevant experience; or a combination of education and experience that enables performance in all aspects of the position.
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