QA Engineer

• Participate in ongoing implementation of the Quality Management System (QMS) in conformance with US FDA Quality System Regulations, ISO 13485, IEC 62304, IEC 60601 and IEC 62366-1 and other relevant standards.
• Support the product development team in creation of design history files (DHFs) including product requirements, software and hardware design specifications, design verification and validation test protocols and reports, risk management file, cybersecurity risk files, biocompatibility and sterilization validation deliverables, traceability matrices, etc.
• Guide and lead risk management activities, including failure modes and effects analysis (FMEA) and hazards analysis, in alignment with ISO 14971.
• Engage and collaborate with suppliers and support design, development and design transfer activities.
• Support and participate in internal and external audits, coordinating and providing documentation and evidence of compliance.
• Support root cause analysis for nonconformances, defects and CAPAs, issue management, management review and quality data analysis.
• Foster a collaborative environment, champion continuous improvement initiatives and promote a quality culture across the organization.

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