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 🎂
Top Skills
What We Do
LVIS is a leader in cutting edge neural information analysis technologies that can decode brain networks and find cures for neurological diseases. LVIS owns patented technologies and our team includes leaders with strong expertise in neuroscience and engineering from Stanford University. LVIS has been selected to be a member of the Stanford StartX community and the NVIDIA inception program. We have an international team with our headquarter located in Palo Alto, California, USA and we have an office in Gangnam, Seoul, South Korea.
