Junior Quality Engineer
Core
Support daily activities to maintain the quality management system, ensure regulatory compliance for medical devices, and drive process improvements.
Role type
Junior Quality Engineer
Builds
Compliance with FDA CFR 820, ISO 13485:2016, and MDSAP standards for medical devices
Domain
Medical device manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management Systems (QMS) knowledge, problem-solving methodologies (PSP, VRK, VSM, TPI, Lean/Six Sigma), validation/qualification (IQ/OQ/PQ), CAPA management, complaint investigation, regulatory audit support, data analysis, Microsoft Office (advanced Excel), ERP/LMS proficiency, documentation accuracy
Preferred skills
Regulated medical device/pharmaceutical environment experience, regulatory audit participation, complex data/statistical tools management, quality system/regulatory requirement knowledge, cross-functional collaboration, organizational skills, learning agility
Technologies
Microsoft Office, ERP, Learning Management Systems, Statistical tools
Responsibilities
Support incoming inspection, calibration, training, and supplier quality; resolve non-conformance reports and customer complaints; lead/support CAPA investigations; assist in process and equipment validation; support internal/external audits; report QMS status
Seniority
Junior, entry-level IC