Quality Systems Associate (1-year) - Medical Device / EAST / Up to 6K #HHL - #1108498

ration: 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 [email protected]

Alex Goh Hock Leong

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