외국계 의료기-QC매니저(과장급)

Job Summary:
The Manufacturing Quality Control Engineer will provide a critical role in Quality and Production, this person will improve current procedure of quality control, implement and maintain the quality control side of the quality management system (QMS). He/she will also participate in inspections and will make sure that the inspection and the QC system comply with the FDA regulations.

Key responsibilities will include (but are not limited to) the followings:
• Improve and implement the procedures related to:
- Identification and Traceability
- Production and Process Controls
- Acceptance Activities
- Nonconforming Product
- Labeling and Packaging Control
- Handling, Storage, Distribution, and Installation
- Servicing
- Statistical Techniques
• Execute or be involved in:
- Inspection, measuring, and test equipment
- Receiving, in-process, and finished device acceptance
- Device labeling and packaging
- Storage, Servicing
- Production and process controls
- Process validation
- Receiving, in-process, and finished device acceptance
- Handling, Distribution, Installation
- Statistical techniques
• Provides continuous feedback related to inspection, potential concerns, resource needs
• Continually analyzes user requirements/feedback/complaints for the process and product improvements
• Develops, maintains, and achieves departmental goals and objectives in support of site and corporate goals and objectives

REQUIRED ESSENTIAL SKILLS/EXPERIENCE
• Bachelor’s degree in engineering, Quality Management, or equivalent
• 5+ years of experience in electrical medical device with accessories that needs sterilization
• Experience in Management of Manufacturing site and storage area, Suppliers, Equipment, parts and components
• Experience in Process FMEA
• Experience in Material Review Board (MRB)
• Experience in the cleaning, manufacturing process validation and IQ / OQ / PQ / TMV
• Experience in Nonconformance Management (NCRs), Adverse Event Reporting / Recalls
• Experience in Training of the SOP to the team
• Experience in Quality review of records, labelling
• Experience in Receiving, Incoming, In-process, finished device inspections
• Fluent in Korean and ability to communicate effectively and professionally in written English
• Excellent problem-solving, organizational, analytical and critical thinking skills, strict attention to detail.
• Excellent documentation and communication skills
• Practical understanding of Production and process control procedures and applications of functional knowledge and methodologies to solve complex problems within products, processes and/or systems
• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
• Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness
• Self-motivated, Eager to learn and grow