Quality Systems Associate (1-year) - Up to 6K #HHL

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

Job summary

A leading recruitment firm seeks a Quality Engineer for a 12-month contract in Singapore's medical device industry. The role focuses on quality management, including improving compliance and managing documentation processes across the Asia Pacific region. The ideal candidate holds a Bachelor’s degree and possesses at least 5 years of experience in quality management, strong knowledge of ISO standards, and effective communication skills.

Qualifications

• Minimum 5 years’ experience in quality/manufacturing within the medical device industry.
• Strong knowledge of ISO 13485 and regulatory requirements.
• Knowledge of medical device or pharmaceutical documentation regulations.

Responsibilities

• Implement and maintain product inspection and release processes.
• Maintain compliance with country-specific labeling processes.
• Manage and track Quality Hold in 3PL.

Skills

Problem-solving

Communication

Critical thinking

Education

Bachelor’s Degree in a related field

Tools

MS Office Suite

Job description

Duration: 12 Months Contract
Salary: $6000
Working Hours: 5 Days, Office Hours

Warehouse Quality Management

• Implement and maintain product inspection and release processes
• Maintain compliance with country-specific labeling processes
• Manage and track Quality Hold (Global & Local) in 3PL
• Drive improvements for 3PL Quality Management Systems and agreements
• Coordinate rework activities and internal complaints
• Perform First Article Inspection (FAI)
• Ensure warehouse compliance with procedures and work instructions
• Manage and follow up SCARs

Asia Pacific Quality Documentation & Supplier Management

• Act as quality engineer for APAC labeling and quality documentation
• Maintain supplier qualifications and support new supplier onboarding
• Provide supplier quality training and implement supplier control processes

Post Market Quality Assurance

• Maintain product complaint handling processes in APAC
• Execute field corrective actions as Local FCA Coordinator
• Generate quality system reports and trend analysis
• Maintain regional training compliance

Quality Systems & Compliance

• Participate in audits and address audit requests
• Own and manage NCR, CAPA, and PRA in the region
• Assess quality system impacts (ECRs, CAPA) and provide feedback

Requirements:

• Min. Bachelor’s Degree in a related field
• Minimum 5 years’ experience in quality/manufacturing within the medical device industry
• Strong knowledge of ISO 13485 and regulatory requirements
• Proficient in MS Office Suite
• Strong communication, problem-solving, and critical thinking skills
• Knowledge of medical device or pharmaceutical documentation regulations

Interested candidates, do submit your resume to [e-mail] or telegram @alexgohhl

Alex Goh Hock Leong

(CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599)