5 days office hour: Monday to Friday: 8:30 AM - 6:00 PM
Location: Serangoon
Our client is well-known for its expertise in specializing in quality support solutions that help reduce manufacturing costs worldwide, with a particular focus on the North and East regions of America.
Responsibilities:
Ensure ISO13485 and FDA 21 CFR Part 820 systems are well-maintained and improved.
Work with different teams to promote understanding of the Quality Management System, identify gaps, and provide guidance.
Manage quality audits, making sure findings are addressed and reported to management.
Ensure procedures from the Quality Management System are followed.
Review the Quality Management System for improvements.
Organize training sessions for ISO13485, ISO14971, and FDA 21 CFR Part 820.
Plan external audits and maintain compliance with quality standards.
Mentor and supervise as needed and support audits and special projects.
Be ready to travel for supplier and customer visits.
Requirements:
Bachelor\'s Degree in Quality Management or Electronics Engineering.
At least 3 years of Quality Management System experience in manufacturing.
Strong knowledge of ISO13485 and FDA 21 CFR Part 820.
Leadership, problem-solving, and communication skills.
Experience with FDA inspections is a plus.
Job Type Permanent Full Time
Working Hours 5 days office hour: Monday to Friday: 8:30 AM - 6:00 PM