J&J Family of Companies [Medical] Associate QA Specialist in Yongsan-gu, South Korea
Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
포지션: Associate QA Specialist
계열사: 존슨앤드존슨 메디칼 (Medical Devices)
근무지: 서울시 용산구
Quality Assurance & Quality System
Execute quality assurance programs designed to ensure continuous distribution of products consistent with established standard.
Performs quality support duties for quality system management including maintenance of the corrective action and preventive action (CAPA)
Provides support for special quality projects such as new standard deployment, process change for new regulatory requirements, etc.
Receive product complaints via internal system, phone, email, and oral communication and input the information into database
Communicate with quality engineers, manufacturers, and sales representatives to capture and document detailed complaint information for investigation
Coordinate the return of complaint devices from the market by collaboration with commercial team and customer service team
Arrange for inspection and packing of the returned devices and ship the products to overseas decontamination/evaluation labs for analysis
Document and maintain data related to complaint handling activities
Prepare monthly complaint monitoring analysis report for announcement
Prepare complaint analysis results for management review twice a year
Examine and determine the trend of complaints by products, frequencies, or any outstanding problems
Provide guidance and directions to internal employees and external distributors for handling and reporting of complaints
Assist government inspections on medical devices, drugs, and quasi-drugs regulatory compliance
Assist corporate audits on enterprise quality policy standards compliance
Communicate with Health Authority (MFDS) regarding complaint investigation results and CAPA status for adverse events directly reported to MFDS from hospitals
Minimum Bachelor’s degree is required.
Experience in Quality or Regulatory Affairs is preferred (not mandatory).
Knowledge of quality system and regulatory environment.
Excellent communication and strong interpersonal skills.
Experience preferred from a multi-national or regional company.
Fluent in English both oral or written.
Manages activities within Enterprise Complaint Management(ECM) system.
Maintains complaint handling procedures and forms and revises those, if required
Supports audits and inspections.
[JD 확인 및 지원 방법]
www.careers.jnj.com -> Requisition number 1805633639W 검색 -> 해당 모집 공고 클릭 후, “Apply Now”
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Johnson & Johnson Medical Korea (Ltd.) (7225)