QA Engineer #65191

ANRADUS PTE. LTD.; Singapore; On-site; SGD 80,000 - 100,000; Full time

Job summary

A leading company in the manufacturing sector is seeking a QA Engineer to maintain and improve their Quality Management System. The ideal candidate will have strong knowledge of ISO 13485 and FDA regulations, with at least 3 years of relevant experience. Responsibilities include coordinating audits, mentoring staff, and ensuring compliance with quality standards. This is a permanent position based in Serangoon, offering a competitive salary package.

Qualifications

• At least 3 years of experience in Quality Management Systems.
• Excellent knowledge of ISO 13485 and FDA 21 CFR Part 820.

Responsibilities

• Ensure compliance with ISO13485 and FDA 21 CFR Part 820.
• Coordinate quality audits and manage corrective actions.
• Mentor and supervise quality projects.

Skills

Communication

Problem-solving

Quality Management

Education

Bachelor’s Degree in Quality Management

Bachelor’s Degree in Electronics Engineering

Job description

Job Description

• Industry/ Organization Type: Manufacturing
• Position Title: QA Engineer / Quality Assurance Engineer
• Working Location: Serangoon
• Working Hours: 5 days (Monday to Friday, 8.30 AM - 6 PM)
• Salary Package: Basic Salary up to $5,500 + OT + Variable Bonus
• Duration: Permanent

Key Responsibilities

• Ensure that ISO13485 and FDA 21 CFR Part 820 systems are adequately maintained, and continuous improvements are implemented
• Coordinate with various functions to ensure awareness and understanding of the Quality Management System.
• Plan and coordinate 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
• Coordinate 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/customers visits
• Any other ad-hoc duties as assigned

APPLY NOW!!!

• Bachelor’s Degree in Quality Management or Electronics Engineering
• At least 3 years of working experience in Quality Management Systems, and in a manufacturing environment
• Excellent hands-on knowledge of Quality Management Systems 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

Kindly apply through ANY of the following methods:

• Submit your application by clicking the APPLY button;
• Email your resume to Job(at)anradus.com.sg. Please indicate #65191 on the email subject.

Anradus Application Policy: We value each application and ensure every resume is reviewed. Our process is efficient, typically concluding within 3 working days. If you do not receive communication from us within this timeframe, it’s likely that your application has not been shortlisted by our client. In such cases, we recommend continuing your job search to maximize your opportunities.

Anradus Pte Ltd | EA License No. 20C016 | Angel Lim | EA Reg No: R1769781