Job Description
- Have responsibility for ensuring Quality Systems are implemented, managed and maintained to ensure regulatory requirements are satisfied
- Develop, establish, maintain and continuously improve quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of systems and products conform to established standards and Regulatory guidelines and corporate policies
- ISO 13485, Good Manufacturing Process(GMP), cGMP
Daily Responsibilities
- Develop and manage corporate quality process and documents
- Establish quality metrics and verification/validation procedures, conducting required test procedures and report the results
- Follow regulatory/corporate standards, requirements and guidances, translate them into operating units and development process
- Lead internal/external audit (1~2 a year) and management reviews
Qualification
- BS in EECS or related majors
- 3+ years of SW development, project management or QA/QC for commercial HW/SW products
- previous collaboration experience/understanding with quality/test team would be a big plus
- thorough understanding across the entire product (SW) development process
- good skills at communication, collaboration and documentation
- Korean, business-level English
Location
- Seoul, South Korea
- Office in Gangnam and remote work
Benefit
- National health insurance and pension, severance pay
- Stock option
- Support training and related career development program
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