1 Year Contract Associate Specialist, Quality Systems Engineer ( Medical Device MNC ) UP 5.8K #HYT

RECRUIT EXPRESS PTE LTD; Singapore; On-site; SGD 50,000 - 75,000; Full time

Job summary

A leading company in the medical device sector is seeking an Associate Specialist, Quality Systems. This role involves managing warehouse quality operations, ensuring compliance with regulatory standards, and overseeing supplier management activities. The ideal candidate will have a Bachelor's degree and experience in quality or manufacturing, particularly within the medical devices industry.

Qualifications

• Minimum 3 years of experience in quality or manufacturing, ideally in medical devices.
• Strong knowledge of ISO 13485 and quality assurance processes.

Responsibilities

• Implement and maintain quality processes, manage supplier quality, and perform audits.
• Generate quality reports and manage complaints in APAC.

Skills

ISO 13485

Medical/Pharma Documentation

Quality Systems

Strong Analytical Skills

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