1 Year Contract Quality System Specialist [Must have Medical Devices Commercial QA Exp] Up 6K @[...]

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

Job summary

A recruiting agency in Singapore is looking for a Warehouse Quality Management professional. The role involves managing quality assurance activities, supplier quality, and compliance in the medical device industry. The ideal candidate holds a Bachelor's degree and has at least 3 years of relevant experience. Strong attention to detail and the ability to work in a fast-paced team environment are essential.

Qualifications

• 3 years of previous experience in quality and/or manufacturing environment in medical device industry.
• Good understanding of medical devices regulations (e.g. ISO13485).
• Ability to manage competing priorities in a fast-paced environment.

Responsibilities

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

Skills

Attention to detail

Knowledge of medical regulations

Ability to work in a team

Project management

Education

Bachelor’s degree in related field

Tools

JDE system

Job description

Warehouse Quality Management

Overview

Responsibilities and scope include quality management activities in the warehouse, supplier quality, and post-market quality assurance for APAC regions.

Responsibilities

• 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

Education/ Experience (Required)

• Bachelor’s degree in related field
• 3 years of previous experience in quality and/or manufacturing environment in the medical device industry
• Good knowledge of medical or pharmaceutical regulations as relating to documentation
• Good understanding of medical devices regulations (e.g. ISO13485)
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Must be able to work in a team environment, including immediate supervisor and other team members in the section or group

Tele me at @jacechooo or WA me at https://wa.me/[phone] NOW!

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

Jace Choo Oi Kei
Personnel EA License No.: R1875164
Recruit Express Pte Ltd (EA Licence No.: 99C4599)