Quality Assurance Engineer

Job description

Job DetailsJob Location: Corporate - INDIANAPOLIS, IN 46222Position Type: Full TimeJob Category: QA - Quality ControlSummary The Quality Assurance Engineer will support the organization towards compliance of Corporate Quality and Environmental policies, provide leadership, expertise, and guidance for all Quality and Regulatory activities, and assist with required quality and technical tasks. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Ensure compliance with FDA, ISO 13485, and other relevant regulatory standards for medical device manufacturing. Develop and implement quality management system documents for product design, development, and manufacturing. Conduct internal and external audits of quality systems to ensure adherence to quality standards. Coordinate the activities for Quality Management System (QMS) review and present the supporting data and metrics Review and approve manufacturing process changes impacting product quality, including changes to equipment and...