Senior Quality Systems Specialist

Job Title:
Senior Quality Systems Specialist
Location: Singapore (Remote)
Contract Duration: 12 Months
Work Type: Full-time Contract
Start Date: As soon as possible

Job Overview

We are looking for an experienced Senior Quality Systems Specialist to support our client's quality and regulatory compliance activities within the medical device industry. The role will focus on implementing and improving Quality Management Systems (QMS), supporting GDP/GDPMDS certification, and ensuring compliance with Singapore HSA regulatory requirements.

• Implement, maintain, and improve ISO 13485-based Quality Management Systems.
• Lead and support GDP/GDPMDS certification activities.
• Ensure compliance with Singapore HSA medical device regulations.
• Prepare and maintain quality documentation, SOPs, and audit records.
• Coordinate with certification bodies, accreditation bodies, and regulatory authorities.
• Support quality system initiatives for regional operations and commercialization across Southeast Asia.

• Bachelor's degree or higher in Life Sciences or a related discipline.
• 5-7 years of experience in Quality Assurance or Quality Systems within the medical device industry.
• Strong experience with ISO 13485-based QMS implementation and improvement.
• Hands-on knowledge of Singapore HSA regulatory requirements.
• Experience supporting or leading GDP/GDPMDS certification projects.
• Proven experience in obtaining and maintaining GDP certification.
• Experience working with certification bodies and regulatory authorities.
• Proficiency in Microsoft Office.

Preferred Experience: Knowledge of medical device quality and regulatory requirements in Malaysia.