QA Manager
Core
Ensuring adherence to the MIM/GE HealthCare Quality Management System and regulatory requirements for MIM Software, including patient safety and audit readiness.
Role type
Senior Quality Assurance Manager (Regulated Industry)
Builds
Robust and efficient Quality Management System (QMS) for MIM Software
Domain
Medical Device Software / Software as a Medical Device (SaMD)
Deliverable
client delivery
Required skills
Root cause analysis, regulatory compliance management, team leadership, risk assessment, process improvement, document control, complaint management, CAPA management, audit support, stakeholder collaboration
Preferred skills
Experience in Design Engineering or Manufacturing Engineering, expertise in risk mitigation strategies, proficiency in managing multiple priorities
Technologies
FDA CFR 21 820, ISO 13485, MDSAP
Responsibilities
Ensure QMS processes meet quality and regulatory standards; Write, update, and review quality documents and procedures; Investigate nonconformities and determine root cause; Support audits by delivering accurate records; Participate in risk assessments and mitigation strategies; Implement improvements to drive compliance and efficiency.
Seniority
Senior, hands-on IC with management responsibilities