Job Overview
The Quality Systems Specialist plays a pivotal role in maintaining and enhancing the Quality Management System to ensure stringent compliance, meticulous documentation control, and uncompromising product quality.
* Develop and manage QMS documentation to meet regulatory standards, ensuring seamless integration and efficient workflows.
* Craft and review SOPs to guarantee compliance, clarity, and adherence to established protocols.
* Provide support for internal audits, CAPA, and change control processes, fostering a culture of continuous improvement.
* Track and report quality metrics to site leadership, informing strategic decisions and driving business growth.
* Collaborate cross-functionally with QA teams to advance quality initiatives and implement process enhancements.
* Identify and execute process improvements within the QMS, leveraging expertise and industry knowledge.
* Maintain timely, accurate, and compliant QA documentation updates, aligning with organizational objectives.
Requirements
* Hold a degree in Science, Engineering, Quality, or a related field, demonstrating a solid foundation in relevant principles.
* Accumulate at least one year's experience in a regulated or medical device environment, showcasing adaptability and transferable skills.
* Demonstrate a strong understanding of QMS principles and document control, with a keen eye for detail and analytical prowess.
* Exhibit proficiency in root cause analysis and problem-solving, applying logical thinking and creative solutions.
* Possess exceptional organization, communication, and time management skills, facilitating effective collaboration and project delivery.
* Be proficient in Microsoft Office and ERP systems, leveraging technology to drive efficiency and productivity.