QA Specialist

Role Overview

We are hiring a QA Specialist (2+ years) to support day-to-day QMS operations and audit readiness for medical devices, including SaMD/digital health products. The role will contribute to our transition to FDA QMSR (effective Feb 2, 2026; ISO 13485:2016 incorporated by reference) and alignment with Korean DMPA/kGMP requirements.

This is a hands-on role focused on documentation, coordination, and evidence management within the QMS.

Requirements:
Key Responsibilities

• Support operation and maintenance of the QMS (ISO 13485–based)
• Administer Document Control in an eQMS (Dot Compliance is a plus): document lifecycle, routing/e-sign, training linkage, and recordkeeping
• Support Change Control and CAPA execution: tracking, documentation, and effectiveness checks
• Support Supplier Quality activities: ASL maintenance, SCAR issuance/follow-up, supplier quality records
• Support ISO 14971 Risk Management documentation (e.g., hazard analysis/FMEA/traceability updates in collaboration with cross-functional teams)
• Support CSV for non-product systems (eQMS, issue trackers, cloud tools): plan/test/evidence/approval
• Support SaMD QMS deliverables: awareness of IEC 62304 concepts, traceability (RTM), V&V evidence organization
• Support internal/external audit preparation and help maintain QA training materials/records
• Support updates to SOPs/forms/training based on DMPA, kGMP, and other regulatory/QMS changes

Minimum Qualifications

• 2+ years of QA experience in a regulated industry (medical devices preferred; pharma QA experience can be considered)
• Familiarity with ISO 13485-based QMS; basic understanding/exposure to risk management concepts (ISO 14971 is a plus)

• Hands-on experience in at least two of the following: Document Control, CAPA, Change Control, Supplier Quality, Audit support
• Basic understanding of CSV for business/non-product systems (documentation and evidence-focused)
• Strong Korean technical writing skills; comfortable reading/writing English documents and emails (fluent spoken English not required)

Preferred Qualifications

• Experience supporting SaMD/software development environments (issue trackers, requirements/traceability, V&V documentation)
• Experience with eQMS tools (Dot Compliance preferred) and electronic signature/training record workflows
• Experience supporting kGMP-related QMS documentation or audit readiness
• Experience delivering or coordinating QA training sessions/materials

Work Arrangement

• On-site in Seoul (Gangnam). Occasional calls with global teams across time zones.

Notes

• Applicants are encouraged to apply even if they do not meet every requirement, provided they have strong documentation discipline and a willingness to learn.

Interview Process

• Phone Screening → Online Interview (1–2 rounds) → Final Interview → Reference Check → Offer

Benefits:
• Flexible working hours (start between 7:30–9:00 AM)
• Public holidays and Labor Day off
• Flat, open, and casual culture
• Snacks, coffee, and tea provided
• Modern office with high-performance equipment
• Early leave on birthdays 🎂