Senior Quality Systems Specialist

Scalence; Singapore; Remote; SGD 90,000 - 130,000; Full time

Job summary

Scalence is seeking a Senior Quality Systems Specialist in Singapore (Remote) to drive and improve our quality management systems for medical devices. You will lead ISO 13485 implementation, support GDP/GDPMDS certification, and ensure compliance with Singapore HSA regulations.

The role requires a Bachelor’s degree in Life Sciences and 5–7 years of experience in QA/QMS within medical devices, with hands-on regulatory coordination and documentation, audits, and cross-functional collaboration

Qualifications

• 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.

Responsibilities

• 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.

Skills

QA experience

QMS

ISO 13485

GDP/GDPMDS

Singapore HSA

Regulatory coordination

Education

Bachelor's degree in Life Sciences or related

Job description

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.

Key Responsibilities

• 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.

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.
• 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.