1 year Contract Quality Assurance Specialist (Medical Devices/ Up to $5000) #HGN

RECRUIT EXPRESS PTE LTD; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading company in Singapore is seeking a Quality Assurance professional to assist in developing and maintaining their Quality Management System while ensuring compliance with ISO 13485 standards. This role involves managing document controls, conducting internal audits, and collaborating on risk management activities. The successful candidate will possess a diploma or degree and have 2-3 years of relevant experience. Candidates are encouraged to apply via email with their resume and details of their experience.

Qualifications

• Diploma or Degree holder required.
• Min 2-3 years of experience in QA is essential.

Responsibilities

• Develop and maintain Quality Management System (QMS) in compliance with ISO 13485.
• Perform internal audits and CAPA monitoring.
• Investigate customer complaints and coordinate corrective actions.

Skills

Quality Management System (QMS)

Risk Management

Data Analysis

Document Control

Internal Audits

Education

Diploma or Degree

Tools

Livelink

PLM

Learning Management System (LMS)

Trackwise

Job description

Responsibilities

• Assist to develop and maintain Quality Management System(QMS) in compliance with ISO 13485

• Responsible for document control, change control and training management

• Assist QA Management in preparation of materials and follow up actions for Management Review and management meetings.

• Monitor and ensure activities required for maintenance of QMS are performed, including risk management, supplier management and internal audit

• Administer or coordinate Livelink, PLM, Learning Management System (LMS) and Trackwise in Singapore.

• Develop documentation system, maintain controls and documentation procedures

• Perform qualification, verification or User Acceptance Tests of software or changes to software

• Perform QC work in the absence of QC Specialist

• Analyze data to identify areas for improvement in quality system.

• lnvestigate Customer complaint and non-conformance issues and monitor to ensure closure.

• Coordinate the Corrective and Preventive Action (CAPA) system and monitor to ensure timely closure.

• Perform internal audits and follow up with departments on CAPA.

• Participate in and monitor Risk Management activities related to SADC processes and softwares.

• Verify and document any defects found during inspection of products and liaison with Manufacturers.

• Perform any product recalls from international countries with distribution.

• Perform supplier qualification, audit, corrective action request and improvement

• Perform duties related to QMS based on Singapore Customs requirements

• Have a sound understanding of, and comply with, the Code of Conduct and Company compliance requirements

• Perform any other duties assigned by QA Management

Requirements

• Diploma or Degree holder

• Min 2-3 years of experience

All Interested candidates are invited to email your resume in MS Word format to:

[e-mail]

Please include your full working experience, education background, notice period, expected salary.

Nerissa Goh Jia Ying (R21103899)

Recruit Express Pte Ltd

Company Reg. No. 199601303W | EA License Number: 99C4599

Recruiter's ref code: #HGN

We regret to inform that only suitable candidates will be shortlisted for an interview.