Job Opportunities API

Work Flexibility: Hybrid Key areas of responsibility •    Support post-market surveillance (PMS) activities, including complaint handling, product field actions, adverse event reporting, UDI reporting, and other activities in accordance with applicable local regulatory requirements. •    Support Quality Management System (QMS) activities to ensure compliance with internal procedures and applicable regulatory requirements. •    Support the maintenance and control of QMS documentation, including procedures, work instructions, forms, and quality records. •    Support communications and document preparation for regulatory authorities and Notified Bodies, as applicable. •    Assist with QMS improvement initiatives and process updates under the guidance of the QA team. •    Assist with cross-functional QA projects and support QMS-related systems and documentation. •    Perform other QA administrative and operational tasks as assigned. Education / work experience • BS in a science, engineering, business or related discipline. • 0+ years experience in manufacturing environment or equivalent. Knowledge / competencies • Good command of written and spoken English. • Strong documentation skills with attention to detail. • Basic understanding of Quality Management System (QMS) and applicable regulatory requirements. • Proficiency in Microsoft Office applications (Excel, Word, and PowerPoint) and data management. • Strong communication and interpersonal skills with the ability to work effectively in a cross-functional environment. • Good organizational and problem-solving skills with the ability to manage multiple tasks. Travel Percentage: None