QA Specialist

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