Testimonials

Product Quality Engineer (Direct hire) / Atlanta metro

Summary Product Quality Engineer supports projects, activities, and processes to improve systems and quality. He/she collects and analyzes data and generates performance reports. This position will initiate steps in continuous improvement and report findings to the VP of Quality. This position will play a key role in assisting to drive quality throughout the organization. Essential Functions Provide engineering support to operations ensuring consistent application of quality techniques. Resolve quality issues of capability, tolerancing, and materials related issues. Resolve quality issues by identifying problems, examining solution options, implementing action plans, and providing resources. Effectively communicate and reinforce commitment to quality improvement efforts. Coordinate with Sales, Engineering, Contract Manufacturer, and Customer Service to resolve customer complaints and concerns. Drive supplier quality development through the facilitation of supplier surveys and onsite supplier audits, monitor supplier performance through NCR and delivery schedule and partner for continuous improvement activities. Interface with customers and vendors to provide technical support for our products and assures quality of incoming materials. Initiate nonconformance reports and corrective action for nonconforming material and assist in defect identification and troubleshooting where necessary with suppliers. Develop and implements methods and procedures for disposition of nonconforming material and ensures that effective root cause analysis is conducted; track implementation of corrective/preventive actions. Working with ISO 13485 standards and 21CFR 820 regulations for medical device products. Develop root cause for non-conformances and deviations. Develop and implement methods for sampling, inspection, testing and evaluation of products. Develop and implement statistical methods and design experiments to support process control, process/product improvement. Support research and development and contract manufacturing to ensure successful transition of products and processes from design to production. Initiate process improvement projects to increase efficiency, reduce costs, simplify processes, and improve quality. Support process and test method validation activities by developing and executing protocols for new or existing processes. Develop and initiate standards and methods for inspection, testing and evaluation. Develop and write internal specifications, work instructions, supplier part specifications, and internal test methods. Trained as an internal auditor and perform quality audits. Knowledge, Skills and Abilities Demonstrated ability to creatively respond to product quality and customer challenges Excellent customer service skills, both written and verbal Ability to define and drive process improvements in customer service and quality Excellent analytical, documentation, and process development skill Ability to work independently and balance multiple priorities in a fast-paced FDA regulated environment. Ability to read, analyze and interpret complex document to drive improvement or change. Ability to work collaboratively across various department throughout the organization. Education and Experience Bachelor’s degree in Engineering, preferably BioEngineering 0-5 plus years of experience in the medical device industry 0-5 years of related experience with Quality and Supply Chain preferred. American Society for Quality Certification as a Quality Auditor or Quality Engineer preferred Must understand, follow, and comply with regulatory requirements as applicable to various processes. An understanding of FDA Quality System Regulations and ISO Standards (ISO 13485) is required. Must possess a thorough understanding of work related standards and regulations, including but not limited to Standard Operating Procedures (SOPs) and Quality System Regulations (QSRs), both US and international. Strong organization and planning skills with an attention to detail and accuracy. Strong verbal and written communication skills; ability to write technical reports, specifications and work instructions and convey technical information. Proficient computer skills and demonstrates competence to include Word, Excel, PowerPoint, Visio. Working knowledge of inspection methods, blue print reading, statistics, process capability, and managing supplier quality Please submit MS Word resume to HR@isg-resources.com

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