We are looking for a Quality Assurance Specialist to join a global apparel and fashion organization in Secaucus, New Jersey. This Long-term Contract opportunity combines quality assurance coordination with administrative support, offering a key role in keeping product submissions, documentation, and reporting organized and on schedule. The position partners closely with quality leadership, suppliers, and factory teams to help maintain visibility into samples, deadlines, and quality-related records.<br><br>Responsibilities:<br>• Provide day-to-day support to quality leadership by managing administrative tasks, organizing priorities, and helping the team stay aligned on deliverables.<br>• Monitor sample activity from submission through follow-up, ensuring items are logged accurately and tracked against required timelines.<br>• Maintain organized quality documentation and update records so information is current, accessible, and audit-ready.<br>• Prepare and distribute Excel-based reports that highlight status updates, open items, and progress against deadlines.<br>• Communicate with suppliers and factory partners to gather missing information, confirm expectations, and resolve outstanding submissions.<br>• Follow up consistently on pending approvals, late deliverables, and incomplete documentation to keep projects moving forward.<br>• Assist with coordination across the QA function to support product quality processes and reporting needs.<br>• Help manage scheduling, reporting, and other operational tasks that contribute to an efficient quality assurance workflow.
<p>Benefits:</p><ul><li>medical</li><li>dental insurance</li><li>vision care</li><li>401k plan</li><li>paid time off</li></ul><p>Responsibilities</p><ul><li>Support the development, maintenance, and continuous improvement of quality systems within a regulated medical device environment. </li><li>This role will be responsible for ensuring compliance with FDA Quality Management System Regulations (QMSR), ISO 13485, and EU Medical Device Regulation (MDR) requirements. </li><li>Maintain and improve the Quality Management System (QMS) to ensure compliance with FDA QMSR, ISO 13485, and EU MDR requirements.</li><li>Support product development activities by participating in design reviews, risk management, verification and validation, and design control processes.</li><li>Review and approve quality system documentation, including procedures, work instructions, specifications, and records.</li><li>Lead or support investigations involving nonconformances, complaints, deviations, CAPAs, and root cause analysis.</li><li>Partner with Engineering, Manufacturing, Regulatory Affairs, and Operations teams to ensure quality requirements are effectively implemented.</li><li>Support internal, supplier, customer, and regulatory audits, including audit preparation, response coordination, and corrective action implementation.</li></ul>