North-East Jobs Qa Engineer Position at Aurora Technology Pte Ltd

Job Info

Company	Aurora Technology Pte Ltd
Position	Qa Engineer
Region	North-East
Career Level	Senior Executive
Work Experience	3 years
Qualification	Advanced/Higher/Graduate Diploma, Bachelor's Degree, Diploma, Master's Degree, Post Graduate Diploma, Professional Degree
Type of Work	Full-Time
Minimum Salary	SGD 3.200
Maximum Salary	SGD 5.500

Responsibilities:

• Ensure that ISO13485 and FDA 21 CFR Part 820 systems are adequately maintained, and continuous improvements are implemented
• Co-ordinate with various functions to ensure awareness and understanding of the Quality Management System. Plan and co-ordinate gap analysis exercises and provide advice on bridging the gap
• Manage and oversee quality audits by plan and ensure quality audits findings and recommendations are rectified and implemented. Apprise management of quality audit findings and corrective actions taken
• Ensure that the procedures and processes prescribed by the Quality Management System are in place and implemented per requirement
• Review the Quality Management System periodically to assess continued suitability and areas of possible improvement
• Arrange for ISO13485, ISO14971 and FDA 21 CFR Part 820 awareness training and further refresher training as needed
• Co-ordinate and plan work of external audit such as Customer, ISO certification and Regulatory bodies
• Ensure that systems and procedures are in compliance with ISO13485, ISO14971, FDA 21CFR Part 820, and GDP requirements
• Mentor/supervise as assigned and ensure timely and accurate completion of quality projects
• Support Plant wide audit/ inspection activities and special projects, as assigned
• Able to travel for suppliers/customer visits

Requirements:

• Bachelor’s Degree in Quality Management or Engineering
• At least 3 years of working experience in Quality Management System, and in manufacturing environment
• Excellent hands on knowledge of Quality Management System primarily in ISO 13485 and FDA 21 CFR Part 820
• Lead, mentor and facilitate problem solving and quality improvements
• Establish controls system required in ISO13485 & FDA registered facility
• Strong communication and interpersonal skills
• FDA Inspection experience preferred

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Company Description

Company Info

• Industry: Manufacturing / Production
• Registration No.: 200201194N
• Company Size: 1 - 50 Employees
• Benefits & Others: Regular hours, Mondays - Fridays, Business (e.g. Shirts)