[의료기기/품질관리] Quality Control Medical Robot

An international medical device manufacturer is searching for a Quality Control Medical Robot. The selected applicant will be improving and implementing procedures that ensure our products meet stringent quality standards.

Responsibilities:

• Improve and implement procedures related to identification and traceability, production and process controls, acceptance activities, nonconforming product, labelling and packaging control, handling, storage, distribution, and installation
• Execute or be involved in inspection, measuring, and test equipment; receiving, in-process, and finished device acceptance; device labelling and packaging; storage, servicing; production and process controls; process validation
• Provide continuous feedback related to inspection, potential concerns, resource needs
• Continually analyse user requirements, feedback, and complaints for the process and product improvements
• Develop, maintain, and achieve departmental goals and objectives in support of site and corporate goals and objectives

Requirements:

• Bachelor’s degree or equivalent in engineering, quality management
• More than 5 years of experience in electrical medical devices with accessories that need sterilisation
• Experience in management of manufacturing site, storage area, suppliers, equipment, parts, and components
• Experience in Process FMEA
• Experience in Material Review Board
• Experience in the cleaning, manufacturing process validation, and IQ, OQ, PQ, TMV
• Experience in Nonconformance Management (NCRs), Adverse Event Reporting or Recalls
• Experience in Quality review of records and labelling
• Fluent in Korean; proficient in written English

About the Company:

Based in the United States, this international medical device company specialises in the development of innovative endovascular robotic systems.

Keywords:

품질관리, 엔지니어링, 의료기기, 제조사, 의료, 국제

2071430/001
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