QMS 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.