Posted:12 hours ago|
Platform:
Work from Office
Full Time
Strong knowledge of FDA QSR, ISO 13485, EUMDR & regulatory norms. Manage QMS docs, DHFs, CAPAs, audits, suppliers, training & calibration. Support audits, product dev, quality improvements & regulatory compliance. Excellent doc & comm skills needed.QMS Management: Take ownership of QMS documentation, ensuring it's current, accurate, and accessible. Regulatory Compliance: Apply strong knowledge of FDA Quality System Regulation (QSR), ISO 13485, and EU Medical Device Regulation (EUMDR) to all quality processes. Design History Files (DHFs): Manage and maintain Design History Files, ensuring completeness and compliance throughout the product development lifecycle. CAPA Management: Lead and support Corrective and Preventive Actions (CAPAs), from initiation and investigation to implementation and verification of effectiveness. Audits: Facilitate and support internal and external audits (e.g., regulatory inspections, notified body audits), ensuring readiness and effective follow-up on findings. Supplier Quality: Oversee supplier qualification, monitoring, and quality agreements to ensure high standards across our supply chain. Training & Calibration: Manage and track quality-related training programs and ensure timely calibration of essential equipment. Cross-functional Collaboration: Partner with teams like Product Development to integrate quality requirements early in the design process and support overall quality improvements. Regulatory Submissions: Provide critical support for regulatory submissions, ensuring all necessary quality documentation is complete and accurate.
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