Quality Compliance Engineer
Core
Conducting internal and external audits, managing non-conformance reports, and leading root cause analysis to ensure compliance with ISO:13485 standards for intelligent product manufacturing.
Role type
Quality Compliance Engineer
Builds
Compliance frameworks and corrective action plans for medical device manufacturing
Domain
Medical device manufacturing / Quality Management Systems
Deliverable
client delivery
Required skills
ISO:13485 audit execution, root cause analysis, corrective and preventative action (CAPA) planning, non-conformance report generation, stakeholder management for audit issues
Preferred skills
EUMDR and MDSAP knowledge, Engineering Change Request (ECR) management, Unique Device Identification (UDI) and Global Trade Item Number (GTIN) understanding
Responsibilities
Setting up and owning internal audit schedules, hosting external audits for customers or certification bodies, creating non-conformance reports, performing root cause analysis, advising on corrective and preventative actions
Seniority
Mid-level, hands-on IC