[의료기기/품질관리] Sr. Quality Assurance Specialist

A multinational medical device manufacturer needs a Sr. Quality Assurance Specialist. The candidate selected will be accountable for guarantee the seamless operation of QA and RA initiatives.

Responsibilities:

• Enhance the quality system in line with appropriate laws and requirements
• Oversee quality assurance operations
• Conduct internal and external audits as well as statistical analysis
• Define and resolve product quality issues
• Drive test method validation processes
• Manage calibration and preventive maintenance programs
• Liaise with engineering personnel to create adequate inspection criteria

Requirements:

• Bachelor’s degree or above in quality or engineering
• 10+ years of experience in quality assurance, quality engineering, or a similar position within the medical device manufacturing business
• Valid ASQ certification is advantageous
• Prior experience with software validation is ideal
• Excellent analytical and problem-solving abilities
• Business level written English

About the Company:

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

1710350/001