About the role The Quality Assurance (QA) & Regulatory Manager is responsible for overseeing and ensuring the quality, safety and compliance of products with relevant regulatory standards and industry best practices. Reporting directly to the Global Director of Engineering, this role has multiple direct reports and requires strong leadership skills, technical expertise, and an in-depth understanding of quality management systems (QMS), regulatory requirements, and continuous improvement initiatives. What you will be doing + Manage and direct in-process quality improvement initiatives within the Odessa facility to achieve quality goals. + Achieves QA operational objectives by reporting quality information and analysis to strategic reviews; preparing and completing action plans; implementing production, productivity, quality, and service standards; identifying and resolving problems; and implementing system improvements. + Develops quality assurance plans by conducting hazard analyses; identifying critical control points and preventative measures; establishing control limits; monitoring procedures, corrective action, and verification; monitoring inventories. + Directs the product inspection activities to ensure that each product delivered to customers meets or exceeds documented standards as well as the general quality expectations of customers. + Maintains compliance and improves product quality by completing regular surveillance audits; investigating customer complaints; collaborating with other members of management to develop new engineering designs, and manufacturing and training methods. + Prepares quality reports for review and action by management; by collecting, analyzing and summarizing trends and process failures, capability studies, validation results, recalls, and corrective actions. + Collaborates with customers, key account managers, product managers, and engineers to support product qualification document requirements, and deliver products that meets customer expectations. + Coordinates, plans, hosts, and responds to periodic product safety and compliance audits by customers and regulatory bodies. + Identifies and drives QMS improvements that streamline and accelerate the business, while maintaining regulatory compliance and ensuring safe, high-quality products. + Supports management in identifying and resolving resource issues, bottlenecks, quality and safety risks. How you will be making an impact + Play a pivotal role in bringing cutting-edge medical devices to market, supporting technology innovation that improves human health, and shaping the future of our company's success. + Help maintain the company's reputation for high-quality, reliable, and user-friendly mobile carts and articulating arms for medical devices. + Ensure that the company remains in compliance with external standards and laws. About you + Bachelor's degree in Business, Engineering, or a related field. + Minimum 5 years of experience as a Quality Assurance/Regulatory Manager or Engineer. + Demonstrated analytical/statistical knowledge and problem-solving skills. How will we reward you + Opportunity to work on challenging and rewarding projects, shaping the future of medical technology and the company. + Collaborative and dynamic work environment with talented and passionate individuals. + Continuous learning and development opportunities to help you grow your skills and career.