QMS Engineer
Core
Establishing and maintaining a compliant Quality Management System (QMS) for device activities, ensuring regulatory adherence and continuous improvement.
Role type
Mid-level QMS Engineer
Builds
Compliant QMS processes, documentation, and audit readiness
Domain
Medical device manufacturing / Regulatory Quality
Required skills
Document control, QMS documentation management, ISO 13485/FDA QMSR/EU MDR knowledge, Root cause analysis, Corrective actions, Non-conformance reporting, Internal audit participation, Risk management, Data analysis, Process improvement
Preferred skills
PLM/Windchill experience, Training content development, Agile methodology
Technologies
Windchill, PLM systems
Responsibilities
Develop and revise QMS process documents (SOPs, quality manuals), Collect and report QMS performance metrics, Participate in internal and external audits, Engage in risk management activities, Collaborate with cross-functional teams on quality issues
Seniority
Mid-level, hands-on IC