The Quality Associate II – Quality Management System (QMS) supports the development, maintenance, and continuous improvement of the QMS in alignment with ISO 13485, ISO 9001, FDA QMSR, MDSAP and other applicable requirements. This role focuses on Corrective and Preventative Actions (CAPAs), internal audits, supporting external audits, training, batch release, supplier qualification and quality agreements, and QMS-level risk management. The position ensures the QMS remains compliant, effective, and inspection-ready.
QMS QUALITY OVERSIGHT
Administer and maintain QMS processes including CAPAs, internal audits and training Standard Operating Procedures (SOPs).
Lead or support CAPA investigations, ensuring strong root-cause analysis, effectiveness checks, and timely closure.
Support internal audit planning, execution, reporting, and follow-up activities.
Support Quality Assurance (QA) Manager and QMS Documentation Lead with document control and change management activities, i...