Overview
Remote
Depends on Experience
Contract - W2
Skills
ISO 13485
Management
Medical Devices
QMS
Quality Assurance
Regulatory Affairs
Regulatory Compliance
Risk Management
Job Details
- We are seeking a Senior Device QA Manager to lead quality assurance activities for medical devices and combination products.
- The role includes overseeing supplier qualification, change controls, CAPAs, design assurance, risk management, and regulatory compliance.
- Candidates should have 10+ years in device QA/RA and strong knowledge of QMS, FDA, and ISO 13485 regulations.
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