QA Manager / QA System Engineer - 2842
GSAPQMS Ownership & Hands-On Operations QMS Maintenance: Maintain and improve the QMS to ensure full compliance with ISO 13485 and EU /MDR / IVDR / QMSR / ISO 27001 Document Control: Manage the document control process, including Device History Files (DHF) and Device Master Records (DMR). NC, CAPA & Complaints: Lead investigations for nonconforming products, customer complaints, and Corrective and Preventive Actions (CAPA). Core Processes: Execute daily activities for change control, deviations, training control. CRB Chair: Chair the Corrective Action Review Board (CRB) meetings. Supplier Management: Maintain the Approved Supplier List (ASL), approve new suppliers, manage Supplier Corrective Action Reports (SCARs), and approve Quality Assurance Agreements (QAA). Executive Oversight: Lead management reviews, facilitate and track QMS objectives, and execute quality plans. Leading 3rd party Audits: Lead ISO 13485, MDR, IVDR, audits Production & Operations Support Product Release: Perform Device History Record (DHR) reviews, approve QC tests, and grant final product release. Facility Control: Oversee equipment maintenance, calibration activities, and environmental monitoring. Operational Quality: Initiate, investigate, and approve deviations and Non-Conformances (NCs). Incoming Goods: Oversee purchasing controls and perform incoming inspections for materials. Cross-Functional Support Regulatory Affairs: Support technical documentation maintenance, labeling updates, standards monitoring, Post-Market Surveillance (PMS), and adverse event reporting. Commercial Support: Review customer orders and assist marketing with technical requests as needed. Support and facilitate feedback process. Culture: Advocate for QMS compliance and build a strong quality culture across the company.