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 ...