[commercial QA & PMS Exp] 12M Contract QA Specialist - Medical Device UP$6K #HJA

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

Job summary

A leading recruitment agency in Singapore is seeking a Quality Manager to oversee quality management processes in the medical device sector. The ideal candidate will implement quality protocols, ensure supplier compliance, and manage product complaints in the Asia Pacific region. Candidates should have a bachelor's degree and a minimum of three years' experience in quality management. Interested applicants should submit their resume via email.

Qualifications

• 3 years of experience in quality and/or manufacturing within the medical device industry.
• Experience with quality management systems and regulatory compliance.

Responsibilities

• Implement and maintain Product Inspection and Release Processes.
• Drive improvement in 3PL Quality Management Systems.
• Manage compliance for Product Complaint Handling Process in APAC.

Skills

Quality Management

Supplier Management

Regulatory Compliance

Audit Participation

Education

Bachelor’s degree in related field

Job description

Key Responsibilities

Warehouse Quality Management

• Implement and maintain Product Inspection Process and Product Release Process, including Imported Finished Goods, and Returned Products
• Maintain compliance of country specific labeling process
• Implement and track Quality Hold(Global & local) in 3PL
• Drive improvement for 3PL Quality Management System, implement and maintain Quality Agreements
• Drive and execute rework activities
• Initiate and track internal complaints resulting from labeling and other regulatory non-compliance
• Perform first article inspection (FAI) for product distributed in Asia Pacific & greater China region
• Ensure implementation of company’s procedure/work instruction in warehouse
• Manage and follow up SCARs
• Act as quality engineer for Asia Pacific labeling and other quality documentation
• Supplier Management
• Maintain existing supplier and support in new supplier qualification
• Provide Quality Training to suppliers
• Implement Supplier Control Process

Post Market Quality Assurance

• Oversight and maintain compliance of Product Complaint Handling Process in APAC includes receiving and reporting complaints to CH Center, following up Complaint Investigation, sample return etc.
• Execute Field Corrective Action Process includes operations in JDE system. Act as Local FCA Coordinator for Region
• Generate quality system reports and perform trend analysis
• Maintain training compliance for region
• Participate on audit teams by responding and gathering data to address audit requests
• Own and manage NCR, CAPA, PRA in region
• Assess the impact of quality systems information (e.g., Enterprise Change Requests (ECRs), CAPA) and provide feedback to originators
• Other incidental duties

Experience (Required)

• Bachelor’s degree in related field
• 3 years of previous experience in quality and/or manufacturing environment in the medical device industry

TELE me at @yijingggggg or WA me at https://wa.me/[phone] NOW!

Interested candidates, please submit your resume to [e-mail]

Alison Chen

CEI Reg No: R25126657

Recruit Express Pte Ltd (EA Licence No.: 99C4599)