QA Specialist (1-year Contract)

Job description

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