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

RECRUIT EXPRESS PTE LTD; Singapore; On-site; SGD 50,000 - 70,000; Full time

Job summary

A leading recruitment agency is seeking a Quality Management professional in Singapore to implement and maintain quality processes within the medical device industry. The ideal candidate will have at least 3 years of experience and a related Bachelor's degree. Responsibilities include overseeing product inspections and managing supplier quality compliance. Interested candidates are encouraged to apply via the provided email.

Qualifications

• 3 years of previous experience in quality and/or manufacturing environment in the medical device industry.

Responsibilities

• Implement and maintain Product Inspection Process and Product Release Process.
• Drive improvement for 3PL Quality Management System.

Skills

Quality Management

Supplier Management

Training

Regulatory Compliance

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)