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

Recruit Express Pte Ltd.; Singapore; On-site; SGD 80,000 - 100,000; Full time

Job summary

A leading recruitment agency is seeking a Quality System Specialist in Singapore. The role requires managing product inspection processes and ensuring compliance with medical device regulations. Ideal candidates should hold a degree and have at least 3 years of QA experience in the medical industry. Competitive salary up to 6K SGD monthly.

Qualifications

• 3 years of previous experience in quality and/or manufacturing in medical device industry.
• Good knowledge of medical or pharmaceutical regulations.
• Good understanding of medical devices regulations like ISO13485.

Responsibilities

• Implement and track Product Inspection Process and Quality Hold.
• Maintain compliance of country specific labeling process.
• Oversee Product Complaint Handling Process in APAC.

Skills

Attention to detail

Team collaboration

Knowledge of medical regulations

Quality management experience

Education

Bachelor's degree in related field

Job description

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

Warehouse Quality Management

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 including 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)