Senior Lead Auditor (Medical Devices)
Core
Lead and maintain a risk-based internal and supplier audit program to ensure regulatory compliance for regulated medical device features.
Role type
Senior Lead Auditor (Medical Devices)
Builds
Internal audit program and supplier quality program for health and wellness products
Domain
Medical Devices / Regulatory Compliance
Required skills
Quality Management Systems audit processes, ISO 13485, MDSAP, China GMP, EU MDR, ISO 14971, ISO 62366, ISO 62304, supplier qualification, supplier corrective actions, supplier monitoring, audit report generation, external audit preparation, global regulation monitoring, quality system best practices
Preferred skills
Software medical device products, Lead auditor certification, internal auditor certification
Technologies
ISO 13485, MDSAP, China GMP, EU MDR, ISO 14971, ISO 62366, ISO 62304
Responsibilities
Lead and maintain risk-based internal and supplier audit program, Conduct audits per international regulatory requirements, Manage supplier quality program including qualification and monitoring, Generate audit reports, Support external audits, Monitor changes to global regulations
Seniority
Senior, hands-on IC
