외국계 의료기- RA/QA (과/차장)

Job Summary
The QA/RA Manager will implement and maintain the corporate quality management system (QMS) and ensure compliance with all applicable domestic and international regulations (US Code of Federal Regulations, relevant Medical Device Regulations, and ISO standards). He/she executes, leads and manages Quality audits, CAPA, Management review and Quality plan.

Key responsibilities will include (but are not limited to) the followings:
• Oversees the whole Quality system procedures and write, review and make an improvement of the quality management system
• Oversees development and effectiveness of the quality management system including Corrective and Preventive Action, Training, Internal/ external audits, and customer complaints
• Supports site activity for regulatory objectives, requirements, and submissions
• Implement compliant Supplier Quality and Internal Audit management controls that meet and/or exceed FDA, MDR, and ISO requirements
• Develops, maintains, and achieves departmental goals and objectives in support of site and corporate goals and objectives
• Reviews and evaluates relevant industry guidelines for applicable Quality and Regulatory requirements and provides feedback regarding potential issues, risks or challenges
• Continually analyzes user feedback/complaints for ongoing component, process and product improvements
• Supports, implements and verifies corrective actions for long term effectiveness
• Provides continuous feedback to on project activities, product performance, potential concerns, resource needs and the cost of quality trends promoting an open communication policy
• Serves as leading correspondence for the audits and investigations
• Make sure that the product follows the Quality management system and the procedure


REQUIRED ESSENTIAL SKILLS/EXPERIENCE
• Bachelor's Degree in Engineering, Science, Quality Management, or equivalent
• 7+ years of experience in electro-mechanical medical device with accessories that needs sterilization
• Main correspondence of cGMP, ISO 13485, KGMP or MDSAP Audits
• Established quality management system from a scratch
• Experience in Management Review, CAPA, Quality plan
• Fluent in Korean and able to communicate effectively and professionally in written and spoken English
• Excellent problem-solving, organizational, analytical and critical thinking skills and strict attention to detail.
• Excellent documentation and communication skills with ability to drive achievement of objectives.
• Practical understanding of Quality system management and ability to fill up the gap in any QMS
• Require the ability to change the thinking of, or gain acceptance from others in sensitive situations, without damage to the relationship.
• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment.
• Ability to maximize best practice sharing and team effectiveness.
• Self-motivated, Eager to learn and grow

PREFERRED REQUIREMENTS
• ASQ certification
• Experience in eQMS, Start-ups, Capital equipment, De-novo, PMA, IEC 80601-1