This position is open exclusively to people who are eligible to work in USA Overview Seeking a Quality Engineer within the medical device industry to support quality assurance activities, compliance, and continuous improvement initiatives in a regulated environment. Required Experience 3+ years of experience in Quality Engineering within medical device or regulated industry Strong knowledge of FDA regulations (21 CFR Part 820) and ISO 13485 Experience with CAPA, NCR, and Root Cause Analysis Hands‑on experience in validation (IQ/OQ/PQ) and process improvements Familiarity with risk management (FMEA) and documentation control Key Responsibilities Support quality systems to ensure compliance with regulatory and company standards Lead and participate in CAPA investigations and root cause analysis Review and maintain quality documentation including SOPs and validation reports Collaborate with cross-functional teams on process improvements and audits Assist in internal/external audits and ensure timely closure of findings #J-18808-Ljbffr
Quality Engineer - Medical Device
SHOOLIN INC
vancouver, vancouver
Published 27 days ago
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