Quality Engineer I
Core
Ensures compliance with FDA QMSR, ISO 13485, and EU MDR regulations through quality system procedures, investigations, and validation activities for medical device products.
Role type
Junior IC quality engineer (medical devices)
Builds
Quality system procedures, validation protocols, risk assessments, and compliance documentation for medical device manufacturing.
Domain
Medical technology / Regulated manufacturing
Required skills
FDA QMSR compliance, ISO 13485, EU MDR, CAPA processes, failure investigations, environmental monitoring, calibration, risk assessment (FMEA/FTA), validation protocols, statistical analysis, Microsoft Office, Minitab
Preferred skills
Six Sigma Green Belt, ASQ certification, microbiological testing, statistical techniques, Lean methodologies
Technologies
Minitab, Microsoft Word, Excel, Visio
Responsibilities
Execute compliance activities for FDA QMSR, ISO 13485, and EU MDR; own quality system investigations including complaints and CAPAs; administer environmental monitoring programs; develop and execute validation protocols and risk assessments; participate in internal and supplier audits; support design transfer and manufacturing process improvements.
Seniority
Junior, entry-level IC