Senior Design Quality Assurance - Electrophysiology
Core
Lead Quality function for sustaining projects of innovative Electrophysiology cardiovascular products, ensuring compliance with regulatory requirements and developing quality-engineering methodologies.
Role type
Senior Design Quality Assurance Engineer
Builds
Sustaining projects for Electrophysiology cardiovascular products
Domain
Medical Device / Electrophysiology / Cardiovascular
Required skills
Medical device engineering, Design verification and validation, Regulatory compliance (FDA, ISO, IEC), Risk management, Statistical analysis, Leadership
Preferred skills
Capital Equipment experience, Software/Firmware validation
Technologies
FDA, ISO 13485, IEC 60601, EN ISO 14971, IEC 62304, EN ISO 13485
Responsibilities
Lead Quality function for product sustaining teams, Provide quality and compliance inputs for project decisions, Support post market product sustaining activities, Create and maintain safety risk management processes, Collaborate to implement effective controls, Support internal and external regulatory audits
Seniority
Senior, hands-on IC