Quality Engineer - Medical Device

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

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