[ref. y63447800] 1 Year Contract Associate Specialist, Quality Systems Engineer ( Medical Device MNC ) UP 5.8K #HYT

Employment Type: 1 Year Contract

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/+6597430026

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