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**Job Function: **
Quality
**Job Sub Function: **
Digital Quality
Job Category:
Professional
All Job Posting Locations:
Seoul, Korea, Republic of
Job Description:
This position is responsible for overseeing and carrying out tasks and projects related to maintaining quality & regulatory compliance activities at Johnson & Johnson MedTech Korea as required by Johnson & Johnson Quality and Compliance requirements as well as local country regulatory requirements.
Main responsibilities are as follows:
- Establishing, implementing, maintaining, and evaluating a highly effective and compliant quality processes for Korea MedTech Deliver operations.
- Independently partnering with local and regional/global Commercial Quality teams, other functional groups and operational leaders to assist in the oversight and monitoring of business critical issues in HSD (Handling, storage and distribution) Quality.
- Close collaboration with Commercial Business Units, Regulatory Affairs, and Supply Chain, etc. to establish and implement strategy and vision of continuous improvement and feedback through assessments and reporting.
- Lead and execute sample management process with close collaboration with commercial and HCC to identify risks and improvement opportunities for Korea.
- Ensures regulatory reporting compliance requirement e.g. Tracking Devices, Unique Devices Identifier data submission, medical devices supply reporting (Track & Trace), Severe Civil Disaster Prevention Implementation Inspection Management (중대시민재해 예방 이행 점검 관리), Implantable medical device liability insurance (인체이식형 의료기기 책임보험) etc.
EDUCATION & EXPERIENCE REQUIREMENTS:
- A minimum bachelor’s degree is required.
- Experienced in regulated industry, preferably in Quality Control, Quality Assurance, or Supply Chain.
- Good knowledge of Good Distribution Practices (GDP), GMP and validation – demonstrated knowledge and application of QSR, ISO9001, ISO13485 and other international standards.
- Knowledge of manufacturing environment or repackaging/relabeling environment
- Certified Auditor of GMP, ISO 9001 or ISO 13845
- Experience preferred from a multi-national or regional company.
- Fluent in English both oral or written.
**Required Skills: **
Preferred Skills:
Coaching, Communication, Compliance Management, Continuous Improvement, Controls Compliance, Digital Assurance, Econometric Models, Issue Escalation, Performance Measurement, Problem Solving, Process Optimization, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Compliance, Standard Operating Procedure (SOP), Technologically Savvy