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