Quality Associate (Medical Device) - 1year #HHL

Recruit Express Pte Ltd.; Singapore; On-site; SGD 50,000 - 80,000; Full time

Job summary

A leading company in the medical device industry is seeking a Quality Associate to implement and maintain quality management processes. The role involves compliance with labeling, supplier management, and complaint handling in the Asia Pacific region. Candidates are required to have a Bachelor's Degree and at least 3 years of experience in the field.

Qualifications

• Minimum 3 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.
• Manage and track Quality Hold (Global & Local) in 3PL.
• Act as quality engineer for APAC labeling and quality documentation.

Skills

ISO 13485 knowledge

Regulatory requirements knowledge

Education

Bachelor’s Degree in a related field

Job description

Quality Associate (Medical Device) - 1year #HHL

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 3 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

Quality Associate (Medical Device) - 1year #HHL

Singapore | Posted: Jul 11, 2025

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 3 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

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)