Duration: 12 Months Contract
Working Hours: 5 Days, Office Hours
Location: Novena
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 [Confidential Information] or telegram @alexgohhl
Alex Goh Hock Leong
(CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599)
