Quality & Regulatory

- Prepare submissions for the new product registration of medical devices
- Perform regulatory assessments with relevant functions on international   standards and Korea national deviations
- Interface with local and global regulations to implement appropriate    regulatory strategies
- Develop and keep a good/strong relationship with the regulatory authorities,    legislators and trade associations

Business Excellence

- Operational Excellence - deploy BE program: approach, content and tools.
- Drive a culture of continuous improvement - through the development and    implementation of the BEST program: including One page Strategy (OPS),    Hoshin Planning, Business Balanced Scorecard, PBE and Process Survey    Tools.
- Facilitate and mentor organization learning and improvement through the    implementation of quality tools and Quality Improvement Competition (QIC).  
- To influence and coach the management at different levels in the    organization that Business Excellence needs to be managed by them with    priority as it supports their business results positively.
- Drive and increase process maturity of BE PST.

We are looking for

- Bachelor¡¯s degree in Electronics Engineering / Biomedical Engineering
- At least 3 years experience for product registrations & regulatory audits
- Total Quality Management(TQM) administration experience
- Plan, organize and prioritize own work routine to meet established schedule    and support the activities both Q&R and BE.
- Must be able to manage multiple tasks and perform with accuracy and with    a high attention to detail.
- Good verbal and written English communication skills