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.