[담당업무]

ㆍDevelops and implements quality system documentation.

ㆍPartner with cross-functional teams during product development to ensure design controls are implemented and maintained per applicable standards (e.g., ISO 13485, 21 CFR Part 820, ISO 14971).

ㆍSupport risk management activities in accordance with ISO 14971 (Risk Analysis, Hazard Analysis, FTA, FMEA, Mitigations).

ㆍDevelops and executes Design Verification and Design Validation protocols and reports to verify the device meets system, software, hardware, and mechanical requirements.

ㆍDevelop design control documentation and manage the Design History File (DHF) and Device Master Record (DMR) (e.g. Design & Development Plan, Design Inputs, Product Requirements, Trace Matrix).

[자격요건]

ㆍBachelor’s degree in engineering, preferably in Biomedical, Mechanical, Electrical, or related field. Material Science degree is also acceptable. Master’s degree is a plus.

ㆍ2+ years of experience in quality engineering. Medical device experience is preferred.

ㆍWorking knowledge of ISO 13485, 21 CFR Part 820, and ISO 14971.