1 Year Contract Regional Quality Assurance Associate (Medical Device Sector ) UP 5.8K #HYT

RECRUIT EXPRESS PTE LTD; Singapore; On-site; SGD 50,000 - 70,000; Full time

Job summary

A leading company in the medical device sector is looking for an Associate Specialist in Quality Systems. The role involves supporting quality operations, managing supplier compliance, and coordinating post-market quality assurance. Ideal candidates will have a Bachelor’s degree and a minimum of 3 years of relevant experience.

Qualifications

• Minimum 3 years of experience in quality or manufacturing, ideally in the medical device sector.
• Strong knowledge of ISO 13485, medical/pharma documentation, and quality systems.

Responsibilities

• Implement and maintain product inspection and rework processes.
• Oversee quality holds and internal complaints.
• Manage product complaint handling and corrective actions.

Skills

Knowledge of ISO 13485

Quality systems

Medical documentation

Education

Bachelor’s Degree in a relevant field

Job description

Now Hiring: Associate Specialist, Quality Systems

Sector: Medical Device / Healthcare
Employment Type: 1 Year Contract

Role Summary:
Support regional quality operations under a transitional service agreement to ensure ongoing compliance with applicable regulatory requirements. Focus areas include warehouse quality management, supplier oversight, and post-market quality assurance.

Key Responsibilities:

Warehouse Quality Management

• Implement and maintain product inspection, release, labeling, and rework processes
• Oversee quality holds (local & global), SCARs, and internal complaints
• Perform First Article Inspections (FAI) for products across Asia Pacific and Greater China
• Ensure compliance with company SOPs at 3PL locations

Supplier Management

• Maintain and qualify suppliers
• Provide quality training and ensure supplier control measures are in place

Post-Market Quality Assurance

• Manage product complaint handling, field corrective actions, and relevant reporting in APAC
• Coordinate with central complaint handling and JDE systems for sample tracking and documentation

Quality Systems & Documentation

• Generate quality reports and trend analysis
• Own and manage NCRs, CAPAs, and PRA activities
• Assess ECRs and contribute feedback for continuous improvement

Audit & Training Support

• Participate in internal/external audits
• Maintain training records for compliance

Requirements:

Education & Experience:

• Bachelor’s Degree in a relevant field
• Minimum 3 years of experience in quality or manufacturing, ideally in the medical device sector

️ Technical & Soft Skills:

• Strong knowledge of ISO 13485, medical/pharma documentation, and quality systems

All qualified applicants, please click “ APPLY NOW”

Or you may send in your resume to:

Whatsapp: https://wa.me/[phone]

Email : [e-mail]

Kimmy Low Yi Ting (Kim) | CEI Registration Number: R23112122

Recruit Express Pte Ltd Company Reg. No. 199601303W | EA LICENCE Number: 99C4599