Job Description

• Serangoon
• $3200 - $5500
• 5 Days / 8.30am to 6pm
• Attractive Remuneration Package

Interested applicants can send your resume to \xe2\x9c\x89 raelynn_ng#thesupremehr.com and allow our Consultants to match you with our Clients. No Charges will be incurred by Candidates for any service rendered.

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
• Establish controls system required in ISO13485 & FDA registered facility
• FDA Inspection experience preferred

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

Additional Information

Career Level

Junior Executive

Qualification

Not Specified

Years of Experience

1 year

Job Type

Full-Time

Job Specializations

,

Company Overview

Here at The Supreme HR Advisory, we pride ourselves on being a vibrant recruitment firm with strong Southeast Asia standing. We believe in customizing our services to your unique needs. We are dedicated, enthusiastic and we take innovative approaches in customizing our services. Our depth of experience enables us to understand each industry\'s challenges and provide expert advice on hiring requirements. Our goal is to leverage on our local knowledge and global expertise to deliver high-quality candidates specifically matched to the requirements of each of our client.

Additional Company Information

Registration No.

201426535W

EA No.

14C7279

Company Size

51 - 200 Employees

Average Processing Time

13 days

Industry

Human Resources Management / Consulting

The Supreme HR Advisory