Senior Quality Systems Specialist

Location: Singapore | Work Type: Remote

Contract Duration: 12 Months

Job Overview

We are looking for an experienced Senior Quality Systems Specialist to support Quality Management System (QMS) implementation, maintenance, and continuous improvement within the medical device industry. The role will focus on Singapore HSA regulatory compliance, ISO 13485 standards, and GDP/GDPMDS certification to support regional operations and commercialization.

The ideal candidate should have strong knowledge of Singapore medical device regulations and the ability to independently lead quality and certification initiatives.

Key Responsibilities

• Implement, maintain, and improve ISO 13485-based Quality Management Systems.
• Lead and support GDP/GDPMDS certification and compliance activities.
• Ensure compliance with Singapore HSA medical device regulatory requirements.
• Coordinate with certification bodies, accreditation bodies, and regulatory authorities.
• Prepare and maintain quality documentation, procedures, and audit records.
• Collaborate with cross-functional teams to support certification and commercialization.
• Support regional quality system activities across Southeast Asia, including Malaysia where applicable.

Required Qualifications

• 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.
• Hands-on experience implementing or improving ISO 13485-based QMS.
• Strong knowledge of Singapore HSA regulatory requirements.
• Demonstrated experience supporting or leading GDP/GDPMDS certification projects.
• Proven track record in obtaining and maintaining GDP certification.
• Experience working with certification bodies, accreditation bodies, and regulatory authorities.
• Proficiency in Microsoft Office applications.

Preferred: Experience with medical device quality systems and regulatory requirements in Malaysia.

Contract: 12 months

Work Arrangement: Remote